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

    PACE-PULSE/COMPUTRAC

    K Number: K800782 · Decision May 28, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    5
    Review Days
    50

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    Basic Information

    Device Name
    PACE-PULSE/COMPUTRAC
    K Number
    K800782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3640
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Bib, Inc.
    Date Received
    April 8, 1980
    Decision Date
    May 28, 1980
    Product Code
    KRE
    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
    KRE Analyzer, Pacemaker Generator Function, Indirect

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