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

    LIFEPAK 500 BIPHASIC

    K Number: K983393 · Decision May 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    227
    Applicant Total
    80
    Review Days
    222

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    Basic Information

    Device Name
    LIFEPAK 500 BIPHASIC
    K Number
    K983393
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.5310
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Physio-Control Corp.
    Date Received
    September 25, 1998
    Decision Date
    May 5, 1999
    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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    Other Clearances by Physio-Control Corp.

    K Number Device Name
    K991910 LIFEPAK 12 BIPHASIC
    K990338 NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
    K973486 LIFE PAK 12
    K962359 LIFEPAK 300
    K955854 LIFEPAK 500
    K953204 PEDIATRIC QUIK-COMBO
    K951593 LIFEPAK 11
    K945511 LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER, AND LIFEPAK 11 CARDIAC MONITOR
    K943301 QUIK COMBO
    K941970 FAST-PATCH
    Search all 80 clearances from Physio-Control Corp. →