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510(k) K090671

PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D by Contec Medical System Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2009
Date Received
March 13, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Contec Medical System Co., Ltd.

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  • 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)
  • 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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