BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    SYSTEM 22 ADULT MASK

    K Number: K940887 · Decision Apr 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    275
    Registration Numbers
    275
    Same Product Code
    54
    Applicant Total
    9
    Review Days
    53

    Basic Information

    Device Name
    SYSTEM 22 ADULT MASK
    K Number
    K940887
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5580
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    MEDIC-AID LTD.
    Date Received
    February 25, 1994
    Decision Date
    April 19, 1994
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (BYG), ordered by most recent decision date.

    FIRST AID KIT(S)

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    HANS RUDOLPH NASAL CPAP MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    DISPOSABLE, CPAP OXYGEN MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    WESTMED PEDIATRIC AND ADULT AEROSOL MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology
    View all

    Other Clearances by MEDIC-AID LTD.

    K Number Device Name
    K991685 HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR
    K981772 HALOLITE AAD SYSTEM
    K971933 PORT-NEB
    K934749 FREEWAY LITE NEBULIZER COMPRESSOR
    K940888 SYSTEM 22 PAEDIATRIC MASK
    K933535 VENTSTREAM DRUG NEBULIZER
    K924123 SIDESTREAM DISPOSABLE
    K914152 SIDESTREAM DRUG NEBULIZER