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.
Device ID | K020362 |
510k Number | K020362 |
Device Name: | P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM |
Classification | Generator, Oxygen, Portable |
Applicant | ON SITE GAS SYSTEMS INC. 35 BUDNEY RD. BUDNEY PARK INDUSTRIAL Newington, CT 06111 |
Contact | C. Barton Gullong |
Correspondent | C. Barton Gullong ON SITE GAS SYSTEMS INC. 35 BUDNEY RD. BUDNEY PARK INDUSTRIAL Newington, CT 06111 |
Product Code | CAW |
CFR Regulation Number | 868.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-04 |
Decision Date | 2002-02-12 |
Summary: | summary |