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 Generation System-1.0 And 5.0.
| Device ID | K021082 |
| 510k Number | K021082 |
| Device Name: | ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 |
| Classification | Generator, Oxygen, Portable |
| Applicant | ON SITE GAS SYSTEMS, INC. 35 BUDNEY RD. BUDNEY INDUSTRIAL PARK Newington,, CT 06111 |
| Contact | C. Barton Gullong |
| Correspondent | C. Barton 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 | 2002-04-03 |
| Decision Date | 2002-05-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001899016 | K021082 | 000 |