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

    TRANSVAGINAL DOPPLER PROBE

    K Number: K031358 · Decision May 9, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    9
    Review Days
    9

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    Basic Information

    Device Name
    TRANSVAGINAL DOPPLER PROBE
    K Number
    K031358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vascular Control Systems, Inc.
    Date Received
    April 30, 2003
    Decision Date
    May 9, 2003
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

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    Other Clearances by Vascular Control Systems, Inc.

    K Number Device Name
    K060573 BURBANK TENACULUM
    K052209 VCS DOPPLER TRANSCEIVER, MODEL 09-0023-01
    K032125 CSTAT, MODELS 09-0014-01 AND 09-0014-02
    K031812 TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
    K030078 BURBANK TENACULUM, MODEL 09-0011-01
    K023154 VCS-A SERIES CLAMP WITH DOPPLER ULTRASOUND, MODEL 09-0007-01 AND 09-0007-02
    K023024 TRANSVAGINAL DOPPLER PROBE, MODEL 09-0006-02
    K011863 VCS-A SERIES CLAMP