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

    ANALYZER, PACER SYSTEM, PSA-5

    K Number: K781144 · Decision Aug 23, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    29
    Applicant Total
    13
    Review Days
    44

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    Basic Information

    Device Name
    ANALYZER, PACER SYSTEM, PSA-5
    K Number
    K781144
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3630
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Edwards Pacemaker Systems
    Date Received
    July 10, 1978
    Decision Date
    August 23, 1978
    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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