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510(k) K082480

CONTEC POCKET FETAL DOPPLER by Contec Medical System Co., Ltd. — Product Code KNG

K082480 is an FDA 510(k) premarket notification submitted by Contec Medical System Co., Ltd. for the device "CONTEC POCKET FETAL DOPPLER". The FDA issued a decision of Substantially Equivalent on February 25, 2009. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Contec Medical System Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2009
Date Received
August 28, 2008
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 System Co., Ltd.

  • K180837 — CONTEC Oxygen Concentrator (January 10, 2019)
  • K131900 — CONTEC ELECTROCARDIOGRAPH (March 5, 2014)
  • K101273 — DYNAMIC ECG SYSTEM MODEL TLC5000 (September 30, 2011)
  • K110156 — AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMETER, (July 27, 2011)
  • K101692 — PATIENT MONITOR (June 28, 2011)
  • K110774 — ELECTRONIC SPHYGMOMANOMETER (May 13, 2011)
  • K101127 — PATIENT MONITOR, MODEL PM50 (June 11, 2010)
  • K090936 — SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A (August 25, 2009)
  • K090671 — PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D (June 11, 2009)
  • K082641 — FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL (November 10, 2008)

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)

FDA data resources