The following data is part of a premarket notification filed by Aoti Ltd. with the FDA for Hyper-box Topical Wound Oxygen System.
| Device ID | K080966 |
| 510k Number | K080966 |
| Device Name: | HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | AOTI LTD. QUALTECH HOUSE PARKMORE BUSINESS PARK WEST Galway, IE |
| Contact | Robbie Walsh |
| Correspondent | Robbie Walsh AOTI LTD. QUALTECH HOUSE PARKMORE BUSINESS PARK WEST Galway, IE |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-04 |
| Decision Date | 2008-08-06 |
| Summary: | summary |