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510(k) K232893

Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) by Contec Medical Systems Co.,Ltd — Product Code KNG

K232893 is an FDA 510(k) premarket notification submitted by Contec Medical Systems Co.,Ltd for the device "Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F)". The FDA issued a decision of Substantially Equivalent on June 14, 2024. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Contec Medical Systems Co.,Ltd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2024
Date Received
September 18, 2023
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

  • K232895 — B-Ultrasound Diagnostic System (May 3, 2024)
  • K232908 — Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound (May 2, 2024)
  • K220245 — Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) (September 28, 2022)
  • 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)
  • 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)
  • K182190 — Fetal Doppler (December 19, 2018)

FDA data resources