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

    EXTERNAL PACEMAKER ANALYZER MODEL PMA-1

    K Number: K903966 · Decision Jun 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    29
    Applicant Total
    37
    Review Days
    295

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    Basic Information

    Device Name
    EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
    K Number
    K903966
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3630
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    August 28, 1990
    Decision Date
    June 19, 1991
    Product Code
    DTC
    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
    DTC Analyzer, Pacemaker Generator Function

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