{
  "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": "Montvale",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "3 Paragon Dr.,",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "PEA",
      "openfda": {
        "device_name": "Endoscope, Accessories, Image Post-Processing For Color Enhancement",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
          "3006786907",
          "3003775006",
          "3042225166",
          "3014605202",
          "3003782610",
          "3011416394",
          "3014055212",
          "3004638277",
          "9610877",
          "3010703925",
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          "3008185830",
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          "3014055212",
          "3004638277",
          "3002808127",
          "3010703925"
        ]
      },
      "zip_code": "07645",
      "applicant": "Pentax of America, Inc.",
      "decision_date": "2019-12-20",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL",
      "advisory_committee": "GU",
      "contact": "William  Goeller",
      "expedited_review_flag": "",
      "k_number": "K190805",
      "state": "NJ",
      "date_received": "2019-03-29",
      "review_advisory_committee": "GU",
      "postal_code": "07645",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}