{
  "format": "devicerts.device.v1",
  "cite_as": "DSP Screening Audiometer, Micro Audiometrics Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/dsp-screening-audiometer-ewo (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/dsp-screening-audiometer-ewo",
    "json_url": "https://devicerts.com/devices/dsp-screening-audiometer-ewo.json",
    "markdown_url": "https://devicerts.com/devices/dsp-screening-audiometer-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": "2026-11-14",
    "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/dsp-screening-audiometer-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": "DSP Screening Audiometer",
    "registry_name": "DSP SCREENING AUDIOMETER",
    "url": "https://devicerts.com/devices/dsp-screening-audiometer-ewo",
    "manufacturer": {
      "name": "Micro Audiometrics Corp.",
      "url": "https://devicerts.com/manufacturers/micro-audiometrics-corp",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K924543",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "EWO"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The DSP Screening Audiometer is a diagnostic device classified as an audiometer, designed to measure hearing sensitivity. It employs digital signal processing (DSP) technology to assess pure-tone air conduction thresholds across standard audiometric frequencies, aiding in the screening and evaluation of hearing function in clinical or screening settings.\n\nThis device is intended for use in clinical environments by trained professionals, such as audiologists or ENT specialists. Supplied as a reusable instrument, it requires no sterilization but must be cleaned and maintained according to manufacturer guidelines. The device is not MRI-safe and is regulated under FDA 510(k) clearance (K924543) with a classification of Class II (EWO). No information on sterility or single-use is provided in the specifications.",
      "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": "K924543",
      "number_label": null,
      "device_udi_di": null,
      "date": "1993-02-26",
      "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": "K924543",
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            }
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    {
      "group": "Classification",
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        {
          "label": "Device class",
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            {
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 874.1050",
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            }
          ]
        },
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          "label": "Advisory committee",
          "values": [
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              "value": "Ear, Nose, Throat",
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}