POGS 33

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 Pogs 33.

Pre-market Notification Details

Device IDK030920
510k NumberK030920
Device Name:POGS 33
ClassificationGenerator, Oxygen, Portable
Applicant ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. BUDNEY INDUSTRIAL PARK Newington,,  CT  06111
ContactFrancis X Hursey
CorrespondentFrancis X Hursey
ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. BUDNEY INDUSTRIAL PARK Newington,,  CT  06111
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-03-24
Decision Date2004-03-10
Summary:summary

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