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

    MODEL PM-20A PHYSIOLOGICAL MONITOR

    K Number: K880756 · Decision Sep 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    403
    Registration Numbers
    403
    Same Product Code
    711
    Applicant Total
    10
    Review Days
    215

    Basic Information

    Device Name
    MODEL PM-20A PHYSIOLOGICAL MONITOR
    K Number
    K880756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    ADVANCED MEDICAL SYSTEMS, INC.
    Date Received
    February 25, 1988
    Decision Date
    September 27, 1988
    Product Code
    DQA
    Advisory Committee
    Cardiovascular
    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
    DQA Oximeter

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