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510(k) K110774

ELECTRONIC SPHYGMOMANOMETER by Contec Medical System Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2011
Date Received
March 21, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
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)
  • 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)
  • 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)

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