The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Golox.
| Device ID | K072723 |
| 510k Number | K072723 |
| Device Name: | RESPIRONICS GOLOX |
| Classification | Unit, Liquid-oxygen, Portable |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Zita A Yurko |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | BYJ |
| CFR Regulation Number | 868.5655 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-09-26 |
| Decision Date | 2008-03-20 |
| Summary: | summary |