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

    HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

    K Number: K871135 · Decision May 12, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    7
    Review Days
    53

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    Basic Information

    Device Name
    HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE
    K Number
    K871135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    First Medical Devices Corp.
    Date Received
    March 20, 1987
    Decision Date
    May 12, 1987
    Product Code
    LDD
    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
    LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

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