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

    MODEL HD-207 BIDIRECTIONAL VELOCITY METER

    K Number: K912409 · Decision Dec 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    71
    Applicant Total
    8
    Review Days
    206

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    Basic Information

    Device Name
    MODEL HD-207 BIDIRECTIONAL VELOCITY METER
    K Number
    K912409
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2880
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Koven and Assoc., Inc.
    Date Received
    May 31, 1991
    Decision Date
    December 23, 1991
    Product Code
    JOP
    Advisory Committee
    Cardiovascular
    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
    JOP Transducer, Ultrasonic

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