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

    HYPERINFLATION SYSTEM

    K Number: K932557 · Decision Jul 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    54
    Applicant Total
    17
    Review Days
    56

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    Basic Information

    Device Name
    HYPERINFLATION SYSTEM
    K Number
    K932557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5330
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Life Shield Healthcare Products, Inc.
    Date Received
    May 27, 1993
    Decision Date
    July 22, 1993
    Product Code
    BZR
    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
    BZR Mixer, Breathing Gases, Anesthesia Inhalation

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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
    K932560 VOLUME VENTILATORS
    K932558 ADULT ANESTHESIA BREATHING CIRCUIT
    K932559 MAPLESON D CIRCUITS
    K932563 VENTILATOR HOSES
    K932191 BREATHING BAGS
    K932193 PEDIATRIC TEMPERATURE MONITORING CIRCUITS
    K932195 ADULT GAS SAMPLING CIRCUITS
    K932192 PEDIATRIC ANESTHESIA CIRCUITS
    Search all 17 clearances from Life Shield Healthcare Products, Inc. →