K090681 is an FDA 510(k) clearance for the TANSCU O2, a Chamber, Oxygen, Topical, Extremity (Class II — Special Controls, product code KPJ), submitted by Electrochemical Oxygen Concepts, Inc. (Lake Bluff, US). The FDA issued a Cleared decision on August 12, 2009, 149 days after receiving the submission on March 16, 2009. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5650.
| 510(k) Number | K090681 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 16, 2009 |
| Decision Date | August 12, 2009 |
| Days to Decision | 149 days |
| Submission Type | Abbreviated |
| 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 |