Cleared Traditional

EC50 MICRO+ SMOKERLYZER

K082315 · Bedfont Scientific, Ltd. · Toxicology
Feb 2010
Decision
537d
Days
Class 2
Risk

About This 510(k) Submission

K082315 is an FDA 510(k) clearance for the EC50 MICRO+ SMOKERLYZER, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Bedfont Scientific, Ltd. (Rochester, Kent, GB). The FDA issued a Cleared decision on February 1, 2010, 537 days after receiving the submission on August 13, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K082315 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2008
Decision Date February 01, 2010
Days to Decision 537 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