K080966 is an FDA 510(k) clearance for the HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM, a Chamber, Oxygen, Topical, Extremity (Class II — Special Controls, product code KPJ), submitted by Aoti , Ltd. (Galway, IE). The FDA issued a Cleared decision on August 6, 2008, 124 days after receiving the submission on April 4, 2008. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5650.
| 510(k) Number | K080966 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 2008 |
| Decision Date | August 06, 2008 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | KPJ — Chamber, Oxygen, Topical, Extremity |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.5650 |