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    FDA 510(k), K162603, Masimo O3 Regional Oximeter System

    FDA 510(k), K162603, Masimo O3 Regional Oximeter System

    $89.00 USD
    $89.00 USD
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    510(K) Number: K162603
    Device Name: Masimo O3 Regional Oximeter System
    Manufacturer:
    Device Classification Name: Oximeter, Tissue Saturation
    Regulation Number: 870.2700
    Classification Product Code: MUD
    Date Received: 09/19/2016
    Decision Date: 05/26/2017
    Regulation Medical Specialty: Cardiovascular

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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