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510(k) K130036

COSENSE CO MONITOR by Capnia, Inc. — Product Code CCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 2014
Date Received
January 7, 2013
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)
  • K121768 — COSENSE (October 31, 2012)

Other clearances for product code CCJ

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  • K201206 — Pivot Breath Sensor (June 30, 2021)
  • K173238 — ToxCO (April 4, 2019)
  • 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)
  • K121768 — COSENSE (October 31, 2012)
  • K082315 — EC50 MICRO+ SMOKERLYZER (February 1, 2010)
  • K080278 — TABATABA COTESTER (November 28, 2008)
  • K070259 — EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR (February 21, 2008)