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510(k) K220245

Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) by Contec Medical Systems Co.,Ltd — Product Code KNG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 2022
Date Received
January 28, 2022
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 Contec Medical Systems Co.,Ltd

  • K232893 — Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fet (June 14, 2024)
  • K232895 — B-Ultrasound Diagnostic System (May 3, 2024)
  • K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound (May 2, 2024)
  • K202757 — CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, AB (April 28, 2021)
  • K201980 — Infrared Thermometer (December 18, 2020)
  • K171360 — CONTEC™ Electrocardiograph (January 22, 2018)
  • K170856 — CMS600P2 B-Ultrasound Diagnostic System (November 17, 2017)
  • K170954 — Portable ECG Monitor (May 30, 2017)
  • K152863 — Portable ECG Monitor (June 22, 2016)
  • K141362 — PULSE OXIMETER CMS50EW (April 23, 2015)

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)
  • 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)
  • K182190 — Fetal Doppler (December 19, 2018)