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    FDA 510(k), K150369, SomnoDent Classic with DentiTrac Micro-recorder

    FDA 510(k), K150369, SomnoDent Classic with DentiTrac Micro-recorder

    $89.00 USD
    $89.00 USD
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    510(K) Number: K150369
    Device Name: SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder
    Manufacturer: SOMNOMED INC.
    Device Classification Name: Sleep Appliances With Patient Monitoring
    Regulation Number: 872.5570
    Classification Product Code: PLC
    Date Received: 02/13/2015
    Decision Date: 06/18/2015
    Regulation Medical Specialty: Dental

    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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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