BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NON REBREATHING MASK

    K Number: K913164 · Decision Jan 15, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    12
    Applicant Total
    11
    Review Days
    182

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    Basic Information

    Device Name
    NON REBREATHING MASK
    K Number
    K913164
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5570
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Specialty Packaging Producs, Inc.
    Date Received
    July 17, 1991
    Decision Date
    January 15, 1992
    Product Code
    KGB
    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
    KGB Mask, Oxygen, Non-Rebreathing

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    Other Clearances by Specialty Packaging Producs, Inc.

    K Number Device Name
    K922492 SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER
    K913163 NON REBREATHING VALVE
    K913422 OXYGEN TUBING, 81503
    K913216 TRACH T ADAPTER
    K913421 NASAL OXYGEN CANNULA, 81585, 81587 & 81589
    K913383 OXYGEN MASKS 81420, 81421, 81471 & 81461
    K913275 VENTURI OXYGEN MASK
    K913220 AEROSOL MASKS, 81426, 81476, 81490 & 81492
    K913455 OXYGEN MASKS 82400 & 82405
    K910896 DISPOSABLE ANESTHESIA BREATHING CIRCUIT
    Search all 11 clearances from Specialty Packaging Producs, Inc. →