{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 9
    }
  },
  "results": [
    {
      "proprietary_name": [
        "Tablo® Hemodialysis System"
      ],
      "establishment_type": [
        "Complaint File Establishment per 21 CFR 820.198",
        "Develop Specifications But Do Not Manufacture At This Facility"
      ],
      "registration": {
        "registration_number": "3010355846",
        "fei_number": "3010355846",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "Outset Medical, Inc.",
        "address_line_1": "3052 Orchard Drive",
        "address_line_2": "",
        "city": "San Jose",
        "state_code": "CA",
        "iso_country_code": "US",
        "zip_code": "95134",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "Outset Medical, Inc.",
          "owner_operator_number": "10047467",
          "official_correspondent": {},
          "contact_address": {
            "address_1": "3052 Orchard Drive",
            "address_2": "",
            "city": "San Jose",
            "state_code": "CA",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "95134"
          }
        }
      },
      "pma_number": "",
      "k_number": "K211370",
      "products": [
        {
          "product_code": "KDI",
          "created_date": "2022-08-17",
          "owner_operator_number": "10047467",
          "exempt": "",
          "openfda": {
            "device_name": "Dialyzer, High Permeability With Or Without Sealed Dialysate System",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.5860",
            "device_class": "2"
          }
        },
        {
          "product_code": "FIP",
          "created_date": "2022-08-17",
          "owner_operator_number": "10047467",
          "exempt": "",
          "openfda": {
            "device_name": "Subsystem, Water Purification",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.5665",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}