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    FDA 510(k), K003154, MIZAR, BASIS BE, SANDMAN DIGITAL

    FDA 510(k), K003154, MIZAR, BASIS BE, SANDMAN DIGITAL

    $89.00 USD
    $89.00 USD
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    510(K) Number: K003154
    Device Name: MIZAR, BASIS BE, SANDMAN DIGITAL
    Manufacturer:
    Device Classification Name: Amplifier, Physiological Signal
    Regulation Number: 882.1835
    Classification Product Code: GWL
    Date Received: 10/10/2000
    Decision Date: 01/05/2001
    Regulation Medical Specialty: Neurology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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