The following data is part of a premarket notification filed by On Site Gas Systems, Inc. with the FDA for Pogs, Model 33c.
| Device ID | K063454 |
| 510k Number | K063454 |
| Device Name: | POGS, MODEL 33C |
| Classification | Generator, Oxygen, Portable |
| Applicant | ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. Newington, CT 06111 |
| Contact | Guy Hatch |
| Correspondent | Guy Hatch ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. 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 | 2006-11-15 |
| Decision Date | 2007-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001899009 | K063454 | 000 |