The following data is part of a premarket notification filed by On Site Gas Systems, Inc. with the FDA for Portable Oxygen Generation System: Pogs 33c.
| Device ID | K041664 |
| 510k Number | K041664 |
| Device Name: | PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C |
| Classification | Generator, Oxygen, Portable |
| Applicant | ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. BUDNEY INDUSTRIAL PARK Newington,, CT 06111 |
| Contact | C. Bart Gullong |
| Correspondent | C. Bart Gullong ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. BUDNEY INDUSTRIAL PARK 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 | 2004-06-18 |
| Decision Date | 2004-07-29 |
| Summary: | summary |