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

    REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S

    K Number: K931484 · Decision Feb 17, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    118
    Registration Numbers
    118
    Same Product Code
    459
    Applicant Total
    18
    Review Days
    330

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    Basic Information

    Device Name
    REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S
    K Number
    K931484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Portable Power Systems, Inc.
    Date Received
    March 24, 1993
    Decision Date
    February 17, 1994
    Product Code
    BZD
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BZD Ventilator, Non-Continuous (Respirator)

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    Other Clearances by Portable Power Systems, Inc.

    K Number Device Name
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    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
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