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510(k) K121768

COSENSE by Capnia, Inc. — Product Code CCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2012
Date Received
June 15, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1430
Review Panel
AN
Submission Type

Other clearances by Capnia, Inc.

  • K151107 — CoSense ETCO Monitor (July 22, 2015)
  • K130036 — COSENSE CO MONITOR (January 14, 2014)

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  • K171129 — CO Check Pro, CO Screen (March 2, 2018)
  • K171408 — Carbon Monoxide Breath Sensor System (COBSS) (September 29, 2017)
  • K151107 — CoSense ETCO Monitor (July 22, 2015)
  • K130036 — COSENSE CO MONITOR (January 14, 2014)
  • K082315 — EC50 MICRO+ SMOKERLYZER (February 1, 2010)
  • K080278 — TABATABA COTESTER (November 28, 2008)
  • K070259 — EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR (February 21, 2008)