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

    LIFE CORP. OXYGEN PAC

    K Number: K855092 · Decision Jan 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    5
    Review Days
    32

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    Basic Information

    Device Name
    LIFE CORP. OXYGEN PAC
    K Number
    K855092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Life Corp.
    Date Received
    December 20, 1985
    Decision Date
    January 21, 1986
    Product Code
    BTL
    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
    BTL Ventilator, Emergency, Powered (Resuscitator)

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    Other Clearances by Life Corp.

    K Number Device Name
    K910699 LIFE-02 (NON-REFILLABLE CYLINDER)
    K910435 LIFE OXYGENPAC 6/12 LPM
    K910434 LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL
    K910201 LIFE O2