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FDA 510(k)

EC50 MICRO+ SMOKERLYZER

K-Number: K082315 · 2010-02-01

ApplicantBedfont Scientific, Ltd.
Decision Date2010-02-01
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EC50 MICRO+ SMOKERLYZER 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 2010-02-01 under 510(k) number K082315. 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 MICRO+ SMOKERLYZER?

EC50 MICRO+ SMOKERLYZER is a medical device that received FDA 510(k) clearance on 2010-02-01. The listed applicant is Bedfont Scientific, Ltd.. The 510(k) number is K082315.

When did EC50 MICRO+ SMOKERLYZER receive FDA 510(k) clearance?

EC50 MICRO+ SMOKERLYZER received FDA 510(k) clearance on 2010-02-01, under 510(k) number K082315.

Who is the listed applicant for EC50 MICRO+ SMOKERLYZER?

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 MICRO+ SMOKERLYZER?

The FDA product code for EC50 MICRO+ SMOKERLYZER 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®K173238ToxCOK070259EC50 TOXCO+ BREATH CARBON MONOXIDE MONITORK000962PICO 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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