{
  "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": "2026-04-13",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Plymouth",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "13700 1st Ave. N",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OLK",
      "openfda": {
        "device_name": "Pulse Oximeter For Over-The-Counter Use",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2700",
        "device_class": "2",
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      "applicant": "Nonin Medical, Inc.",
      "decision_date": "2024-11-13",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "Nonin OTC Pulse Oximeter Model 3250",
      "advisory_committee": "CV",
      "contact": "Lisa  Pray",
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      "k_number": "K211498",
      "state": "MN",
      "date_received": "2021-05-14",
      "review_advisory_committee": "AN",
      "postal_code": "55441",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}