EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR

Analyzer, Gas, Carbon-monoxide, Gaseous-phase

BEDFONT SCIENTIFIC LTD.

The following data is part of a premarket notification filed by Bedfont Scientific Ltd. with the FDA for Ec50 Toxco+ Breath Carbon Monoxide Monitor.

Pre-market Notification Details

Device IDK070259
510k NumberK070259
Device Name:EC50 TOXCO+ BREATH CARBON MONOXIDE MONITOR
ClassificationAnalyzer, Gas, Carbon-monoxide, Gaseous-phase
Applicant BEDFONT SCIENTIFIC LTD. PO BOX 4341 Crofton,  MD  21114
ContactE.j. Smith
CorrespondentDaniel W Lehtonen
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeCCJ  
CFR Regulation Number868.1430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-01-26
Decision Date2008-02-21
Summary:summary

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