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FDA 510(k)

EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR

K-Number: K070259 · 2008-02-21

ApplicantBedfont Scientific, Ltd.
Decision Date2008-02-21
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Bedfont Scientific, Ltd.. It received FDA 510(k) clearance on 2008-02-21 under 510(k) number K070259. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR?

EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR is a medical device that received FDA 510(k) clearance on 2008-02-21. The listed applicant is Bedfont Scientific, Ltd.. The 510(k) number is K070259.

When did EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR receive FDA 510(k) clearance?

EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR received FDA 510(k) clearance on 2008-02-21, under 510(k) number K070259.

Who is the listed applicant for EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR?

The FDA 510(k) record lists Bedfont Scientific, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR?

The FDA product code for EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR is CCJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Bedfont Scientific, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211918iCOquit® Smokerlyzer®K203695NObreath®K173238ToxCOK082315EC50 MICRO+ SMOKERLYZERK000962PICO SMOKERLYZER, MODEL EC-50

Related Devices (Code: CCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253119CoSense ETCO MonitorCapnia, Inc.K211918iCOquit® Smokerlyzer®Bedfont Scientific, Ltd.K201206Pivot Breath SensorCarrot, Inc.K173238ToxCOBedfont Scientific, Ltd.K171129CO Check Pro, CO ScreenMD Diagnostics LimitedK171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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