P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM

Generator, Oxygen, Portable

ON SITE GAS SYSTEMS INC.

The following data is part of a premarket notification filed by On Site Gas Systems Inc. with the FDA for P.o.g.s. 3.3 Portable Oxygen Generator System.

Pre-market Notification Details

Device IDK020362
510k NumberK020362
Device Name:P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM
ClassificationGenerator, Oxygen, Portable
Applicant ON SITE GAS SYSTEMS INC. 35 BUDNEY RD. BUDNEY PARK INDUSTRIAL Newington,  CT  06111
ContactC. Barton Gullong
CorrespondentC. Barton Gullong
ON SITE GAS SYSTEMS INC. 35 BUDNEY RD. BUDNEY PARK INDUSTRIAL Newington,  CT  06111
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-04
Decision Date2002-02-12
Summary:summary

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