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    FDA 510(K) K110569, AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)

    FDA 510(K) K110569, AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)

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    $568.85 USD
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    Device Classification Name    Electrocardiograph, Ambulatory, With Analysis Algorithm
    510(k) Number    K110569
    Device Name    AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
    Applicant    INOVISE MEDICAL, INC.
    Regulation Number    870.2800
    Classification Product Code    MLO  
    Date Received    02/28/2011
    Decision Date    10/24/2011
    Decision    Substantially Equivalent (SESE)
    Regulation Medical Specialty    Cardiovascular

    Total pages: 303  
    Fully redacted pages: 74  
    Content pages: 229 

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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