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510(k) K101273

DYNAMIC ECG SYSTEM MODEL TLC5000 by Contec Medical System Co., Ltd. — Product Code MLO

K101273 is an FDA 510(k) premarket notification submitted by Contec Medical System Co., Ltd. for the device "DYNAMIC ECG SYSTEM MODEL TLC5000". The FDA issued a decision of Substantially Equivalent on September 30, 2011. The device falls under product code MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm), a Class II device regulated under 21 CFR 870.2800. Contec Medical System Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2011
Date Received
May 6, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Contec Medical System Co., Ltd.

  • K180837 — CONTEC Oxygen Concentrator (January 10, 2019)
  • K131900 — CONTEC ELECTROCARDIOGRAPH (March 5, 2014)
  • 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 MLO

  • K241890 — Philips Holter Analysis System (March 21, 2025)
  • K240794 — Frontier X Plus (November 8, 2024)
  • K200833 — RX-1 Rhythm Express Remote Cardiac Monitoring System (September 2, 2020)
  • K193177 — CER-S (August 26, 2020)
  • K182030 — Faros Mobile (November 8, 2018)
  • K140847 — CARDIOSPY ECG HOLTER SYSTEMS (December 5, 2014)
  • K131897 — CV3000 HOLTER ANALYSIS SYSTEM (November 26, 2013)
  • K130660 — AUDICOR CPAM WITH SDB (SINGLE SENSOR) (October 11, 2013)
  • K120462 — AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED (September 20, 2012)
  • K111487 — NH-301 AMBULATORY ECG ANALYSIS SOFTWARE (November 10, 2011)

FDA data resources