VITALOGRAPH-EC60 HYDROGEN MONITOR

System, Breath Measurement

VITALOGRAPH LTD.

The following data is part of a premarket notification filed by Vitalograph Ltd. with the FDA for Vitalograph-ec60 Hydrogen Monitor.

Pre-market Notification Details

Device IDK874892
510k NumberK874892
Device Name:VITALOGRAPH-EC60 HYDROGEN MONITOR
ClassificationSystem, Breath Measurement
Applicant VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa,  KS  66215
ContactLovina G Freeman
CorrespondentLovina G Freeman
VITALOGRAPH LTD. 8347 QUIVIRA RD. Lenexa,  KS  66215
Product CodeNRH  
CFR Regulation Number862.1820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-01
Decision Date1988-06-02

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