{
  "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": {
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    {
      "third_party_flag": "N",
      "city": "Birmingham",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "434 Industrial Ln.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NMD",
      "openfda": {
        "registration_number": [
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        "fei_number": [
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        "device_name": "Oximeter, Tissue Saturation, Reprocessed",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2700",
        "device_class": "2"
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      "zip_code": "35211",
      "applicant": "Hygia Health Services, Inc.",
      "decision_date": "2010-05-04",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA",
      "advisory_committee": "CV",
      "contact": "LAKE  TRECHSEL",
      "expedited_review_flag": "",
      "k_number": "K100523",
      "state": "AL",
      "date_received": "2010-02-24",
      "review_advisory_committee": "CV",
      "postal_code": "35211",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}