Home / 510(k) Clearances / K180419

510(k) K180419

Ultrasonic Doppler (Model YM-2T8) by Shenzhen Imdk Medical Technology Co., Ltd. — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2018
Date Received
February 15, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Ultrasonic, Fetal
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Shenzhen Imdk Medical Technology Co., Ltd.

  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K243118 — Arm Blood Pressure Monitor (model: BPM-A7VL) (November 26, 2024)
  • K233040 — EMS/TENS Massager Device (February 12, 2024)
  • K221979 — Pulse Oximeter (Model C101A2, C101B1, C101A3) (October 16, 2022)
  • K173123 — Pulse Oximeter (August 13, 2018)

Other clearances for product code KNG

  • K252669 — Fetal Doppler U8-25, U9-25 (January 8, 2026)
  • K242846 — Doppler FHR Detector (BF-500D+, BF-560) (June 26, 2025)
  • K233823 — Ultrasonic Fetal Doppler (June 28, 2024)
  • K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fet (June 14, 2024)
  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • K211940 — Fetal Doppler (January 7, 2022)
  • K212084 — Fetal Doppler (November 3, 2021)
  • K191110 — HeraBEAT™ US (November 14, 2019)
  • K182526 — Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD- (May 29, 2019)
  • K182710 — Fetal Doppler, Model FD88 (March 1, 2019)