Cleared Traditional

EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR

K070259 · Bedfont Scientific, Ltd. · Anesthesiology
Feb 2008
Decision
391d
Days
Class 2
Risk

About This 510(k) Submission

K070259 is an FDA 510(k) clearance for the EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by Bedfont Scientific, Ltd. (Crofton, US). The FDA issued a Cleared decision on February 21, 2008, 391 days after receiving the submission on January 26, 2007. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K070259 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2007
Decision Date February 21, 2008
Days to Decision 391 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
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