POGS, MODEL 65/130

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, Model 65/130.

Pre-market Notification Details

Device IDK092636
510k NumberK092636
Device Name:POGS, MODEL 65/130
ClassificationGenerator, Oxygen, Portable
Applicant ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. Newington,  CT  06111
ContactGuy Hatch
CorrespondentGuy Hatch
ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. Newington,  CT  06111
Product CodeCAW  
CFR Regulation Number868.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-08-27
Decision Date2010-01-07
Summary:summary

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