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

    3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM

    K Number: K950739 · Decision Nov 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    36
    Applicant Total
    76
    Review Days
    273

    Basic Information

    Device Name
    3M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM
    K Number
    K950739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M HEALTH CARE, SARNS
    Date Received
    February 17, 1995
    Decision Date
    November 17, 1995
    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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