Cleared Traditional

ToxCO

K173238 · Bedfont Scientific, Ltd. · Anesthesiology
Apr 2019
Decision
546d
Days
Class 2
Risk

About This 510(k) Submission

K173238 is an FDA 510(k) clearance for the ToxCO, 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 April 4, 2019, 546 days after receiving the submission on October 5, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K173238 FDA.gov
FDA Decision Cleared SESE
Date Received October 05, 2017
Decision Date April 04, 2019
Days to Decision 546 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