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

    BREATHING BAGS

    K Number: K932191 · Decision Jul 2, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    18
    Applicant Total
    17
    Review Days
    57

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    Basic Information

    Device Name
    BREATHING BAGS
    K Number
    K932191
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5320
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Life Shield Healthcare Products, Inc.
    Date Received
    May 6, 1993
    Decision Date
    July 2, 1993
    Product Code
    BTC
    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
    BTC Bag, Reservoir

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    Other Clearances by Life Shield Healthcare Products, Inc.

    K Number Device Name
    K932562 GAS SAMPLING LINES AND CONNECTORS
    K932561 GUEDEL AIRWAYS
    K932557 HYPERINFLATION SYSTEM
    K932560 VOLUME VENTILATORS
    K932558 ADULT ANESTHESIA BREATHING CIRCUIT
    K932559 MAPLESON D CIRCUITS
    K932563 VENTILATOR HOSES
    K932193 PEDIATRIC TEMPERATURE MONITORING CIRCUITS
    K932195 ADULT GAS SAMPLING CIRCUITS
    K932192 PEDIATRIC ANESTHESIA CIRCUITS
    Search all 17 clearances from Life Shield Healthcare Products, Inc. →