EC50 Toxco+ Breath Carbon Monoxide Monitor

FDA 510(k) K070259 · Bedfont Scientific, Ltd.

Substantially Equivalent

510(k) numberK070259

Submission

Device name
EC50 Toxco+ Breath Carbon Monoxide Monitor
Applicant
Bedfont Scientific, Ltd.
Crofton, MD, US
Received
January 26, 2007
Decision date
February 21, 2008
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1430
Specialty
Anesthesiology

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K201206Pivot Breath SensorCCJ · Traditional Carrot, Inc.06/30/2021SE
K173238ToxCOCCJ · Traditional Bedfont Scientific, Ltd.04/04/2019SE
K171129CO Check Pro, CO ScreenCCJ · Traditional MD Diagnostics Limited03/02/2018SE
K171408Carbon Monoxide Breath Sensor System (COBSS)CCJ · Traditional Carrot Sense, Inc.09/29/2017SE
K151107CoSense ETCO MonitorCCJ · Special Capnia, Inc.07/22/2015SE
K130036Cosense Co MonitorCCJ · Traditional Capnia, Inc.01/14/2014SE
K121768CosenseCCJ · Traditional Capnia, Inc.10/31/2012SE
K082315EC50 Micro+ SmokerlyzerCCJ · Traditional Bedfont Scientific, Ltd.02/01/2010SE

More from Bedfont Scientific, Ltd.

510(k)DeviceDecision
K211918iCOquit® Smokerlyzer®CCJ · Traditional 12/21/2021SE
K203695NObreath®MXA · Traditional 12/17/2021SE
K173238ToxCOCCJ · Traditional 04/04/2019SE
K082315EC50 Micro+ SmokerlyzerCCJ · Traditional 02/01/2010SE
K000962Pico Smokerlyzer, Model EC-50CCJ · Special 04/20/2000SE

Questions and answers

When was EC50 Toxco+ Breath Carbon Monoxide Monitor cleared by the FDA?

EC50 Toxco+ Breath Carbon Monoxide Monitor (K070259) received a 510(k) decision of Substantially Equivalent on February 21, 2008, 391 days after the submission was received.

What is the product code of K070259?

The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.