BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR

    K Number: K946080 · Decision Aug 2, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    19
    Applicant Total
    18
    Review Days
    232

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    Basic Information

    Device Name
    PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR
    K Number
    K946080
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Portable Power Systems, Inc.
    Date Received
    December 13, 1994
    Decision Date
    August 2, 1995
    Product Code
    FCO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCO Box, Battery, Rechargeable

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    Other Clearances by Portable Power Systems, Inc.

    K Number Device Name
    K970234 SEALED LEAD ACID BATTERY PACK
    K945043 BATTERY PACK #PMX120-18A
    K931348 BATTERY PACK #1005NC
    K931483 REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.
    K933065 BATTERY PACK# S1009LA
    K934439 RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR
    K932823 BATTERY PACK# S1018LA FOR IVAC 4000, 4200 VITAL CHECK
    K934015 RECHARGE REPLACE BATTERY PK SPACELABS 4045 MON/DEFIB
    K934508 BATTERY PACK# S1024NC
    K931484 REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S
    Search all 18 clearances from Portable Power Systems, Inc. →