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

    CADENCE DOPPLER ULTRASOUND SYSTEM

    K Number: K991441 · Decision Dec 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    19
    Review Days
    246

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CADENCE DOPPLER ULTRASOUND SYSTEM
    K Number
    K991441
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medasonics, Inc.
    Date Received
    April 26, 1999
    Decision Date
    December 28, 1999
    Product Code
    KNG
    Advisory Committee
    Obstetrics/Gynecology
    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
    KNG Monitor, Ultrasonic, Fetal

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KNG), ordered by most recent decision date.

    Fetal Doppler U8-25, U9-25

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Doppler FHR Detector (BF-500D+, BF-560)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Ultrasonic Fetal Doppler

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Fetal Doppler

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Medasonics, Inc.

    K Number Device Name
    K962796 NEUROGUARD TRANSCRANIAL DOPPLER ULTRASOUND SYSTEM
    K961116 FIRST BEAT/CARDIO BEAT/CALC
    K914862 CEREBROVASCULAR DIAGNOSTIC SYSTEM; CDS
    K911453 OBTRASOUND STETHOSCOPE FETAL CALC
    K882018 MEDACORD PVL, PERSONAL VASCULAR LABORATORY
    K872292 TRANSPECT TRANSCRANIAL DOPPLER
    K854734 MODEL 5320 TED SEQUENTIAL COMP. DE. COMP. LIMB SLE
    K833588 VASCULAR LABORATORY TREADMILL VT1
    K837481 BF24 DOPPLER MODEL P872 AND P874
    K831393 VASCULAB BLOOD PRESSURE CUFF
    Search all 19 clearances from Medasonics, Inc. →