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

    BARD(R) BIOPOTENTIAL AMPLIFIER II

    K Number: K913875 · Decision Nov 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    26
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    BARD(R) BIOPOTENTIAL AMPLIFIER II
    K Number
    K913875
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2060
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Electrophysiology
    Date Received
    August 29, 1991
    Decision Date
    November 27, 1991
    Product Code
    DRQ
    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
    DRQ Amplifier And Signal Conditioner, Transducer Signal

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