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

    STOCKERT SCP RHYTHM

    K Number: K042374 · Decision Sep 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    36
    Applicant Total
    9
    Review Days
    22

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    Basic Information

    Device Name
    STOCKERT SCP RHYTHM
    K Number
    K042374
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stockert Instrumente GmbH
    Date Received
    September 1, 2004
    Decision Date
    September 23, 2004
    Product Code
    DWA
    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
    DWA Control, Pump Speed, Cardiopulmonary Bypass

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    Other Clearances by Stockert Instrumente GmbH

    K Number Device Name
    K041558 STOCKERTIR PURGE CONTROL (APC) SYSTEM
    K032213 STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
    K023622 STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
    K022280 STOCKERT CORONARY PERFUSION CANNULAE
    K022321 STOCKERT V172-28 VENOUS FEMORAL CANNULA
    K020571 STOCKERT CENTRIFUGAL PUMP CONSOLE
    K011838 CENTRIFUGAL PUMP
    K011088 SIII ALARM AMPLIFIER