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    FDA 510(k), CPAP MASK, DEVILBISS HEALTH CARE, INC.

    FDA 510(k), CPAP MASK, DEVILBISS HEALTH CARE, INC.

    $89.00 USD
    $89.00 USD
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    510(K) Number: K894690
    Device Name: CPAP MASK
    Manufacturer: DEVILBISS HEALTH CARE, INC.
    Device Classification Name: Attachment, Breathing, Positive End Expiratory Pressure
    Regulation Number: 868.5965
    Classification Product Code: BYE
    Date Received: 07/24/1989
    Decision Date: 09/08/1989
    Regulation Medical Specialty: Anesthesiology

    PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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