BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    LIFE SUPPORT FOR TRAUMA AND TRANSPORT

    K Number: K965117 · Decision Jun 26, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    1
    Review Days
    553

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    Basic Information

    Device Name
    LIFE SUPPORT FOR TRAUMA AND TRANSPORT
    K Number
    K965117
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Northrop Grumman Corp.
    Date Received
    December 20, 1996
    Decision Date
    June 26, 1998
    Product Code
    MKJ
    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
    MKJ Automated External Defibrillators (Non-Wearable)

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