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

    S3 CYCLIC RPM CONTROL

    K Number: K971520 · Decision Sep 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    20
    Applicant Total
    13
    Review Days
    138

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    Basic Information

    Device Name
    S3 CYCLIC RPM CONTROL
    K Number
    K971520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4370
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stoeckert Instrumente
    Date Received
    April 25, 1997
    Decision Date
    September 10, 1997
    Product Code
    DWB
    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
    DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

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