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

    PULMONAIR 40 PATIENT MANAGEMENT SYSTEM

    K Number: K901295 · Decision Mar 30, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    56
    Applicant Total
    16
    Review Days
    10

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    Basic Information

    Device Name
    PULMONAIR 40 PATIENT MANAGEMENT SYSTEM
    K Number
    K901295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5170
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    The Medical Group, Inc.
    Date Received
    March 20, 1990
    Decision Date
    March 30, 1990
    Product Code
    IOQ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IOQ Bed, Flotation Therapy, Powered

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