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

    HANDHELD DOPLER/PEN TRANSDUCER 3MHZ

    K Number: K854590 · Decision Apr 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    111
    Review Days
    156

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    Basic Information

    Device Name
    HANDHELD DOPLER/PEN TRANSDUCER 3MHZ
    K Number
    K854590
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems, Inc.
    Date Received
    November 18, 1985
    Decision Date
    April 23, 1986
    Product Code
    JAF
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JAF Monitor, Ultrasonic, Nonfetal

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