K112634 is an FDA 510(k) clearance for the NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP, a Chamber, Oxygen, Topical, Extremity (Class II — Special Controls, product code KPJ), submitted by Inotec Amd , Ltd. (Fairfax, US). The FDA issued a Cleared decision on July 3, 2012, 298 days after receiving the submission on September 9, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5650.
| 510(k) Number | K112634 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 2011 |
| Decision Date | July 03, 2012 |
| Days to Decision | 298 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 |