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

    BATTERY PACKS FOR CARDIOVASCULAR UNITS

    K Number: K881643 · Decision May 17, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    121
    Registration Numbers
    121
    Same Product Code
    424
    Applicant Total
    2
    Review Days
    43

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    Basic Information

    Device Name
    BATTERY PACKS FOR CARDIOVASCULAR UNITS
    K Number
    K881643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Dowit Service Co., Inc.
    Date Received
    April 4, 1988
    Decision Date
    May 17, 1988
    Product Code
    MHX
    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
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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    Other Clearances by Dowit Service Co., Inc.

    K Number Device Name
    K881885 BATTERY PACKS (OTHER THAN CV)