The following data is part of a premarket notification filed by Wjo, Inc with the FDA for Hyperox 101.
| Device ID | K053498 |
| 510k Number | K053498 |
| Device Name: | HYPEROX 101 |
| Classification | Chamber, Hyperbaric |
| Applicant | WJO, INC 424 MILL STREET AT CANAL'S END PLAZA Bristol, PA 19007 |
| Contact | Chris Belletieri |
| Correspondent | Chris Belletieri WJO, INC 424 MILL STREET AT CANAL'S END PLAZA Bristol, PA 19007 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-03-15 |
| Summary: | summary |