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510(k) K171408

Carbon Monoxide Breath Sensor System (COBSS) by Carrot Sense, Inc. — Product Code CCJ

K171408 is an FDA 510(k) premarket notification submitted by Carrot Sense, Inc. for the device "Carbon Monoxide Breath Sensor System (COBSS)". The FDA issued a decision of Substantially Equivalent on September 29, 2017. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2017
Date Received
May 12, 2017
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

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  • K173238 — ToxCO (April 4, 2019)
  • K171129 — CO Check Pro, CO Screen (March 2, 2018)
  • K151107 — CoSense ETCO Monitor (July 22, 2015)
  • K130036 — COSENSE CO MONITOR (January 14, 2014)
  • K121768 — COSENSE (October 31, 2012)
  • K082315 — EC50 MICRO+ SMOKERLYZER (February 1, 2010)
  • K080278 — TABATABA COTESTER (November 28, 2008)

FDA data resources