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

    PORTABLE, BATTERY OPERATED DEFIBRILLATOR

    K Number: K810237 · Decision Feb 19, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    69
    Review Days
    22

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    Basic Information

    Device Name
    PORTABLE, BATTERY OPERATED DEFIBRILLATOR
    K Number
    K810237
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Honeywell, Inc.
    Date Received
    January 28, 1981
    Decision Date
    February 19, 1981
    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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