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510(k) K082641

FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL by Contec Medical System Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2008
Date Received
September 11, 2008
Clearance Type
Special
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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  • 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)

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  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
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