{
  "format": "devicerts.device.v1",
  "cite_as": "Sera Audiometer, Interacoustics A/S. deviCERTS medical device catalogue. https://devicerts.com/devices/sera-ewo (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/sera-ewo",
    "json_url": "https://devicerts.com/devices/sera-ewo.json",
    "markdown_url": "https://devicerts.com/devices/sera-ewo.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/sera-ewo",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Sera Audiometer",
    "registry_name": "Sera",
    "url": "https://devicerts.com/devices/sera-ewo",
    "manufacturer": {
      "name": "Interacoustics A/S",
      "url": "https://devicerts.com/manufacturers/interacoustics-a-s",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "Denmark"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K173567",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "EWO"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Sera is a Class II audiometer, a diagnostic device designed to measure hearing thresholds and assess auditory function. It employs pure-tone air and bone conduction testing, speech audiometry, and impedance measurements to evaluate hearing sensitivity across different frequencies and pathways. The device is intended for clinical use in otolaryngology and audiology settings to aid in the diagnosis and management of hearing disorders.\n\nThe Sera audiometer is supplied as a reusable, non-sterile medical device intended for use in clinical environments such as hospitals, audiology clinics, and ENT (ear, nose, and throat) practices. It operates within standard electrical safety parameters and is not classified as MRI-safe or MRI-conditional. The device is regulated under FDA 510(k) clearance (K173567) and adheres to regulatory requirements outlined in 21 CFR 874.1050. It is distributed with accompanying software and calibration tools, requiring periodic maintenance as specified in the manufacturer’s instructions.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K173567",
      "number_label": null,
      "device_udi_di": null,
      "date": "2018-02-14",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K173567",
              "registries": [
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            }
          ]
        },
        {
          "label": "FDA product code",
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    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
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            }
          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 874.1050",
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Ear, Nose, Throat",
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            }
          ]
        },
        {
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          "values": [
            {
              "value": "SESE",
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        }
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    }
  ]
}