1 0

    FDA 510(k), K082588, GAMMALOC SYSTEM, MODEL 03-00001

    FDA 510(k), K082588, GAMMALOC SYSTEM, MODEL 03-00001

    $89.00 USD
    $89.00 USD
    Sale Sold out
    510(K) Number: K082588
    Device Name: GAMMALOC SYSTEM, MODEL 03-00001
    Manufacturer:
    Device Classification Name: Camera, Scintillation (Gamma)
    Regulation Number: 892.1100
    Classification Product Code: IYX
    Date Received: 09/08/2008
    Decision Date: 12/11/2009
    Regulation Medical Specialty: Radiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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

    View full details