BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1

    K Number: K851149 · Decision Nov 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    37
    Applicant Total
    29
    Review Days
    250

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    Basic Information

    Device Name
    KEY MED TRANSENDOSCOPIC VASCULAR DETECTOR TVD-1
    K Number
    K851149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1540
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Keymed, Inc.
    Date Received
    March 21, 1985
    Decision Date
    November 26, 1985
    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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