BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION

    K Number: K912078 · Decision Aug 20, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    253
    Applicant Total
    76
    Review Days
    102

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    Basic Information

    Device Name
    SARNS SM03 MEMBRANE OXYGENATOR, MODIFICATION
    K Number
    K912078
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4350
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M Health Care, Sarns
    Date Received
    May 10, 1991
    Decision Date
    August 20, 1991
    Product Code
    DTZ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTZ Oxygenator, Cardiopulmonary Bypass

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    Other Clearances by 3M Health Care, Sarns

    K Number Device Name
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