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

    COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER

    K Number: K982651 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    134

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    Basic Information

    Device Name
    COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
    K Number
    K982651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corometrics Medical Systems, Inc.
    Date Received
    July 30, 1998
    Decision Date
    December 11, 1998
    Product Code
    HEL
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HEL Monitor, Heart Rate, Fetal, Ultrasonic

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