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510(k) K131900

CONTEC ELECTROCARDIOGRAPH by Contec Medical System Co., Ltd. — Product Code DPS

K131900 is an FDA 510(k) premarket notification submitted by Contec Medical System Co., Ltd. for the device "CONTEC ELECTROCARDIOGRAPH". The FDA issued a decision of Substantially Equivalent on March 5, 2014. The device falls under product code DPS (Electrocardiograph), a Class II device regulated under 21 CFR 870.2340. Contec Medical System Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2014
Date Received
June 25, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Contec Medical System Co., Ltd.

  • K180837 — CONTEC Oxygen Concentrator (January 10, 2019)
  • 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)
  • K082480 — CONTEC POCKET FETAL DOPPLER (February 25, 2009)
  • K082641 — FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL (November 10, 2008)

Other clearances for product code DPS

  • K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (July 2, 2026)
  • K251670 — MAC 7 Resting ECG Analysis System (January 26, 2026)
  • K252361 — AccurECG Analysis System (v2.0) (December 22, 2025)
  • K252474 — Withings BeamO (SCT02) (November 10, 2025)
  • K250569 — Cardiologs Holter Platform (August 6, 2025)
  • K243252 — ZBPro Diagnostic (July 10, 2025)
  • K243305 — Masimo W1 (April 3, 2025)
  • K241217 — CloudHRV™ System (100-01-001) (January 16, 2025)
  • K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000) (December 17, 2024)
  • K240229 — Masimo W1 (August 8, 2024)

FDA data resources