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510(k) K201206

Pivot Breath Sensor by Carrot, Inc. — Product Code CCJ

K201206 is an FDA 510(k) premarket notification submitted by Carrot, Inc. for the device "Pivot Breath Sensor". The FDA issued a decision of Substantially Equivalent on June 30, 2021. 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
June 30, 2021
Date Received
May 4, 2020
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 for product code CCJ

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  • K211918 — iCOquit® Smokerlyzer® (December 21, 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)
  • 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