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

    OXYGEN MASKS 82400 & 82405

    K Number: K913455 · Decision Oct 2, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    269
    Registration Numbers
    269
    Same Product Code
    54
    Applicant Total
    11
    Review Days
    61

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    Basic Information

    Device Name
    OXYGEN MASKS 82400 & 82405
    K Number
    K913455
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5580
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Specialty Packaging Producs, Inc.
    Date Received
    August 2, 1991
    Decision Date
    October 2, 1991
    Product Code
    BYG
    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
    BYG Mask, Oxygen

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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
    K913164 NON REBREATHING MASK
    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
    K910896 DISPOSABLE ANESTHESIA BREATHING CIRCUIT
    Search all 11 clearances from Specialty Packaging Producs, Inc. →