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

    ARF-1500 CONTINUOUS VENTILATOR

    K Number: K860798 · Decision Jul 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    130
    Registration Numbers
    130
    Same Product Code
    504
    Applicant Total
    3
    Review Days
    128

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    Basic Information

    Device Name
    ARF-1500 CONTINUOUS VENTILATOR
    K Number
    K860798
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5895
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Medimex, Inc.
    Date Received
    March 4, 1986
    Decision Date
    July 10, 1986
    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 Medimex, Inc.

    K Number Device Name
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    K841370 KMA-1300F