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

    INFANT DISPOSABLE BAG MASK RESUSCITATOR

    K Number: K922819 · Decision Nov 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    20
    Review Days
    531

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    Basic Information

    Device Name
    INFANT DISPOSABLE BAG MASK RESUSCITATOR
    K Number
    K922819
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Support Products, Inc.
    Date Received
    June 11, 1992
    Decision Date
    November 24, 1993
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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    Other Clearances by Life Support Products, Inc.

    K Number Device Name
    K941870 LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
    K941871 LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100
    K940934 LIFE VAC
    K936187 LSPI PRESSURE REGULATOR
    K932200 LSPI AUTOMATIC VENTILATOR
    K922691 LSP (MODEL 554) BAG MASK RESUSCITATOR
    K932199 LSPI AUTOMATIC VENTILATOR, MODEL AV3000
    K921553 LSPI INFANT BAG MASK
    K921107 AUTOVAC
    K924217 LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED
    Search all 20 clearances from Life Support Products, Inc. →