The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Golox-93.
| Device ID | K081779 |
| 510k Number | K081779 |
| Device Name: | GOLOX-93 |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Zita A Yurko |
| Correspondent | Zita A Yurko RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-23 |
| Decision Date | 2008-09-19 |
| Summary: | summary |