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

    BATTERY PACK #1005NC

    K Number: K931348 · Decision Feb 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    18
    Review Days
    337

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    Basic Information

    Device Name
    BATTERY PACK #1005NC
    K Number
    K931348
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Portable Power Systems, Inc.
    Date Received
    March 17, 1993
    Decision Date
    February 17, 1994
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Portable Power Systems, Inc.

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    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
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