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

    CARDIOLAB AMPLIFIER MODULE (CAM)

    K Number: K910307 · Decision Apr 12, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    CARDIOLAB AMPLIFIER MODULE (CAM)
    K Number
    K910307
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2050
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Prucka Engineering, Inc.
    Date Received
    January 24, 1991
    Decision Date
    April 12, 1991
    Product Code
    DRR
    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
    DRR Amplifier And Signal Conditioner, Biopotential

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