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

    LIFE O2

    K Number: K910201 · Decision Feb 1, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    LIFE O2
    K Number
    K910201
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Life Corp.
    Date Received
    January 18, 1991
    Decision Date
    February 1, 1991
    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
    K855092 LIFE CORP. OXYGEN PAC