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

    MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002

    K Number: K903018 · Decision Dec 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    165
    Applicant Total
    6
    Review Days
    145

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    Basic Information

    Device Name
    MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002
    K Number
    K903018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medtronic Andover Medical, Inc.
    Date Received
    July 11, 1990
    Decision Date
    December 3, 1990
    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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