BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Ultrasonic Doppler (Model YM-2T8)

    K Number: K180419 · Decision Jul 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    7
    Review Days
    154

    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
    Ultrasonic Doppler (Model YM-2T8)
    K Number
    K180419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Imdk Medical Technology Co., Ltd.
    Date Received
    February 15, 2018
    Decision Date
    July 19, 2018
    Product Code
    KNG
    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
    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 Shenzhen Imdk Medical Technology Co., Ltd.

    K Number Device Name
    K252655 Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)
    K253133 Wrist Blood Pressure Monitor (BPM-W1VL)
    K243118 Arm Blood Pressure Monitor (model: BPM-A7VL)
    K233040 EMS/TENS Massager Device
    K221979 Pulse Oximeter (Model C101A2, C101B1, C101A3)
    K173123 Pulse Oximeter