{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Phoenix",
      "advisory_committee_description": "Ear, Nose, Throat",
      "address_1": "10443 N Cave Creek Rd., Suite 110",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "LWF",
      "openfda": {
        "registration_number": [
          "",
          "3013374101",
          "3005529827",
          "3005951403",
          "3003877407",
          "3016585381",
          "3009134882",
          "3026199641",
          "3009068676",
          "3008808082",
          "3017107376",
          "3017791238",
          "3044150131",
          "3017417635",
          "1038758",
          "3016719957",
          "3009227226",
          "3010610403",
          "1723702",
          "9613926",
          "3027320022",
          "3036893546",
          "3009566748",
          "8010528",
          "3013600135",
          "3004087544",
          "3005761322",
          "3010700223",
          "3007279871",
          "1032347",
          "3004102812",
          "3033883491",
          "9614473",
          "2954718",
          "2528972",
          "3016075803",
          "3022315836",
          "3008255748",
          "9681544",
          "3005083505",
          "3005343641",
          "3016408131",
          "3038636181",
          "3001620590",
          "3043126851",
          "3010200299",
          "3033920060",
          "2434008",
          "3030017177",
          "1818945",
          "3012716038",
          "3004541026",
          "3015168527",
          "3002324535",
          "3041843469",
          "3031218457",
          "3042261316",
          "3014674517",
          "3008763803",
          "3023895623",
          "1926681",
          "3030580282",
          "3016674860",
          "3027605742",
          "3015456954",
          "1417592",
          "3004547763",
          "3036979319",
          "3044777107",
          "8040278",
          "3010401517",
          "3019673082",
          "3024891479",
          "3025583702",
          "8043235",
          "3027579589",
          "2916714",
          "3015200795",
          "2183564",
          "3011919098",
          "3010805190",
          "3008797926",
          "3014314529",
          "1067084",
          "3014107776",
          "3009563903",
          "3011248163",
          "3003767891",
          "3030795695",
          "3013564290",
          "3016170587",
          "3016245348",
          "3006542501",
          "3006572778",
          "3045076483",
          "3010380285",
          "3016450032",
          "9610612",
          "3011956575",
          "3008936260",
          "3011247798",
          "3036795697",
          "3030234167",
          "3012709011",
          "3026544741",
          "3003062321",
          "3011706862",
          "3025440611",
          "3017248108",
          "3014941496",
          "2183924",
          "3003079019",
          "3042276434",
          "3031582434",
          "3014268398",
          "3008774899",
          "3011194487"
        ],
        "fei_number": [
          "",
          "3013374101",
          "3005529827",
          "3005951403",
          "3003877407",
          "3003767844",
          "3016585381",
          "3009134882",
          "3026199641",
          "3009068676",
          "3008808082",
          "3017107376",
          "1000402972",
          "3017791238",
          "3044150131",
          "3017417635",
          "1038758",
          "3016719957",
          "3009227226",
          "3010610403",
          "3027320022",
          "3036893546",
          "3009566748",
          "3003753482",
          "3013600135",
          "3004087544",
          "3005761322",
          "3003547663",
          "3010700223",
          "3007279871",
          "1032347",
          "3004102812",
          "3033883491",
          "3016075803",
          "3022315836",
          "3008255748",
          "3005083505",
          "3005343641",
          "3016408131",
          "3038636181",
          "3001620590",
          "3043126851",
          "3010200299",
          "3033920060",
          "2434008",
          "3000215572",
          "3030017177",
          "1818945",
          "3012716038",
          "3004541026",
          "3015168527",
          "3004216008",
          "3002324535",
          "3041843469",
          "3031218457",
          "3042261316",
          "3014674517",
          "3008763803",
          "3023895623",
          "1926681",
          "3030580282",
          "3016674860",
          "3027605742",
          "3015456954",
          "1417592",
          "3004547763",
          "3036979319",
          "3044777107",
          "3010401517",
          "3019673082",
          "3024891479",
          "3025583702",
          "3027579589",
          "2916714",
          "3015200795",
          "2183564",
          "3011919098",
          "3010805190",
          "3002806315",
          "3008797926",
          "3014314529",
          "3014107776",
          "3009563903",
          "3011248163",
          "3003767891",
          "3030795695",
          "3013564290",
          "3016170587",
          "3016245348",
          "3003495738",
          "3006542501",
          "3006572778",
          "3045076483",
          "3010380285",
          "3002998723",
          "3016450032",
          "3004545991",
          "3011956575",
          "3008936260",
          "3011247798",
          "2981",
          "3036795697",
          "3030234167",
          "3012709011",
          "3026544741",
          "3003062321",
          "3011706862",
          "3025440611",
          "1000116132",
          "3017248108",
          "3014941496",
          "3003079019",
          "3042276434",
          "3031582434",
          "3014268398",
          "3008774899",
          "3011194487"
        ],
        "device_name": "Dilator, Nasal",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3900",
        "device_class": "1"
      },
      "zip_code": "85020",
      "applicant": "Cpapnea Medical Supply",
      "decision_date": "2018-08-03",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "OptiPillows EPAP Mask",
      "advisory_committee": "EN",
      "contact": "Sal T. Hakim",
      "expedited_review_flag": "",
      "k_number": "K181219",
      "state": "AZ",
      "date_received": "2018-05-07",
      "review_advisory_committee": "EN",
      "postal_code": "85020",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}