PICO SMOKERLYZER, MODEL EC-50

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 Pico Smokerlyzer, Model Ec-50.

Pre-market Notification Details

Device IDK000962
510k NumberK000962
Device Name:PICO SMOKERLYZER, MODEL EC-50
ClassificationAnalyzer, Gas, Carbon-monoxide, Gaseous-phase
Applicant BEDFONT SCIENTIFIC LTD. BEDFONT HOUSE HOLYWELL LANE Upchurch, Kent,  GB Me9 7hn
ContactMartin Foxley
CorrespondentMartin Foxley
BEDFONT SCIENTIFIC LTD. BEDFONT HOUSE HOLYWELL LANE Upchurch, Kent,  GB Me9 7hn
Product CodeCCJ  
CFR Regulation Number868.1430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-24
Decision Date2000-04-20

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