Cleared Traditional

iCOquit? Smokerlyzer?

K211918 · Bedfont Scientific, Ltd. · Toxicology
Dec 2021
Decision
183d
Days
Class 2
Risk

About This 510(k) Submission

K211918 is an FDA 510(k) clearance for the iCOquit? Smokerlyzer?, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Bedfont Scientific, Ltd. (Maidstone, Kent, GB). The FDA issued a Cleared decision on December 21, 2021, 183 days after receiving the submission on June 21, 2021. This device falls under the Toxicology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K211918 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2021
Decision Date December 21, 2021
Days to Decision 183 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code CCJ — Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1430