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510(k) K211918

iCOquit® Smokerlyzer® by Bedfont Scientific, Ltd. — Product Code CCJ

K211918 is an FDA 510(k) premarket notification submitted by Bedfont Scientific, Ltd. for the device "iCOquit® Smokerlyzer®". The FDA issued a decision of Substantially Equivalent on December 21, 2021. The device falls under product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1430. Bedfont Scientific, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2021
Date Received
June 21, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Bedfont Scientific, Ltd.

  • K203695 — NObreath® (December 17, 2021)
  • K173238 — ToxCO (April 4, 2019)
  • K082315 — EC50 MICRO+ SMOKERLYZER (February 1, 2010)
  • K070259 — EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR (February 21, 2008)
  • K000962 — PICO SMOKERLYZER, MODEL EC-50 (April 20, 2000)

Other clearances for product code CCJ

  • K253119 — CoSense ETCO Monitor (May 29, 2026)
  • 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)
  • 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