EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR— 510(k) K070259

Name: FDA 510(k) clearance K070259
Creator: U.S. Food and Drug Administration
Published: 2008-02-21

Substantially Equivalent

Bedfont Scientific, Ltd.

FDA 510(k) clearance K070259 for EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR, Substantially Equivalent on 2008-02-21. Applicant: Bedfont Scientific, Ltd.. Device class: 2.

Clearance details

Applicant: Bedfont Scientific, Ltd.
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 2007-01-26
Decision date: 2008-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCJ

view all

K253119 — CoSense ETCO Monitor2026-05-29
K211918 — iCOquit® Smokerlyzer®2021-12-21
K201206 — Pivot Breath Sensor2021-06-30
K173238 — ToxCO2019-04-04
K171129 — CO Check Pro, CO Screen2018-03-02

More clearances from Bedfont Scientific, Ltd.

view all

K203695 — NObreath®2021-12-17
K082315 — EC50 MICRO+ SMOKERLYZER2010-02-01
K000962 — PICO SMOKERLYZER, MODEL EC-502000-04-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.