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

    MAXI-USE O2 DEVICE

    K Number: K861325 · Decision Sep 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    70
    Applicant Total
    18
    Review Days
    153

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    Basic Information

    Device Name
    MAXI-USE O2 DEVICE
    K Number
    K861325
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    B & F Medical Products, Inc.
    Date Received
    April 9, 1986
    Decision Date
    September 9, 1986
    Product Code
    NFB
    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
    NFB Conserver, Oxygen

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    Other Clearances by B & F Medical Products, Inc.

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    K861054 DISPOSABLE RESCUE BREATHING DEVICE
    K853004 PORTABLE OXYGEN UNIT
    K843691 PORTABLE OXYGEN UNIT
    K823532 STOCK #64091-PEDIATRIC OXYGEN MASK
    K811404 TRAVELAIRE
    K802644 EMERG. OXYGEN KIT #65350 & #65399 CASE
    K802646 HAND PERCUSSOR CUP #65210
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