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

    OXY-QUIK MARK IV OXYGEN INHALATOR

    K Number: K811987 · Decision Jul 27, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    44
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    OXY-QUIK MARK IV OXYGEN INHALATOR
    K Number
    K811987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Oxequip Health Ind.
    Date Received
    July 13, 1981
    Decision Date
    July 27, 1981
    Product Code
    DRM
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRM Compressor, Cardiac, External

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    Other Clearances by Oxequip Health Ind.

    K Number Device Name
    K833496 OXYGEN MONITOR/CONTROLLER
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    K800369 TRI PAC MOUTH PROP
    K792356 OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR