{
  "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": "2026-06-01",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Battle Creek",
      "advisory_committee_description": "Dental",
      "address_1": "4602 Beckley Rd.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PLC",
      "openfda": {
        "device_name": "Sleep Appliances With Patient Monitoring",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.5570",
        "device_class": "2",
        "registration_number": [
          "3008186372",
          "3005598536",
          "3013116677",
          "3013950969",
          "3009440973",
          "3010022489",
          "3015674959",
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      },
      "zip_code": "49015",
      "applicant": "Residential Home Sleep Services",
      "decision_date": "2020-04-10",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac",
      "advisory_committee": "DE",
      "contact": "Chris  Gillette",
      "expedited_review_flag": "",
      "k_number": "K190353",
      "state": "MI",
      "date_received": "2019-02-15",
      "review_advisory_committee": "DE",
      "postal_code": "49015",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}