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

    OMNI-VENT, SERIES D

    K Number: K872113 · Decision Mar 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    498
    Applicant Total
    2
    Review Days
    296

    Basic Information

    Device Name
    OMNI-VENT, SERIES D
    K Number
    K872113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    STEIN-GATES MEDICAL EQUIPMENT, INC.
    Date Received
    June 1, 1987
    Decision Date
    March 23, 1988
    Product Code
    CBK
    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
    CBK Ventilator, Continuous, Facility Use

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    Other Clearances by STEIN-GATES MEDICAL EQUIPMENT, INC.

    K Number Device Name
    K881420 OMNI-VENT, SERIES D/MRI