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

    HPM 40 HEART PACEMAKER MONITOR

    K Number: K922742 · Decision Mar 18, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    18
    Review Days
    283

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    Basic Information

    Device Name
    HPM 40 HEART PACEMAKER MONITOR
    K Number
    K922742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3640
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biotronik, GmbH & Co.
    Date Received
    June 8, 1992
    Decision Date
    March 18, 1993
    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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