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

    PACEART CPTS-86/12

    K Number: K915632 · Decision Apr 14, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    9
    Review Days
    119

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    Basic Information

    Device Name
    PACEART CPTS-86/12
    K Number
    K915632
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3640
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paceart, Inc.
    Date Received
    December 17, 1991
    Decision Date
    April 14, 1992
    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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