VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR

Analyzer, Gas, Carbon-monoxide, Gaseous-phase

VITALOGRAPH LTD.

The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph Ec-50 Carbon Monoxide Monitor.

Pre-market Notification Details

Device IDK863420
510k NumberK863420
Device Name:VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
ClassificationAnalyzer, Gas, Carbon-monoxide, Gaseous-phase
Applicant VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa,  KS  66215
ContactLovina G Freeman
CorrespondentLovina G Freeman
VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa,  KS  66215
Product CodeCCJ  
CFR Regulation Number868.1430 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-04
Decision Date1987-01-15

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