CAPNOSAT

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

SPEGAS INDUSTRIES, LTD.

The following data is part of a premarket notification filed by Spegas Industries, Ltd. with the FDA for Capnosat.

Pre-market Notification Details

Device IDK942849
510k NumberK942849
Device Name:CAPNOSAT
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant SPEGAS INDUSTRIES, LTD. HAR HOTZVIM INDUSTRIAL PARK P.O.BOX 23650NDUSRIAL PARK Jerusalem,  IL 91235
ContactSanford Brown
CorrespondentSanford Brown
SPEGAS INDUSTRIES, LTD. HAR HOTZVIM INDUSTRIAL PARK P.O.BOX 23650NDUSRIAL PARK Jerusalem,  IL 91235
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-16
Decision Date1995-02-21

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