The following data is part of a premarket notification filed by On Site Gas Systems, Inc. with the FDA for On Site Gas Systems Portable Oxygen Generator System.
| Device ID | K014078 |
| 510k Number | K014078 |
| Device Name: | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM |
| Classification | Generator, Oxygen, Portable |
| Applicant | ON SITE GAS SYSTEMS, INC. 100 PRODUCTION COURT New Britain, CT 06051 |
| Contact | C. Barton Gullong |
| Correspondent | C. Barton Gullong ON SITE GAS SYSTEMS, INC. 100 PRODUCTION COURT New Britain, CT 06051 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-11 |
| Decision Date | 2002-01-08 |
| Summary: | summary |