K232385 is an FDA 510(k) clearance for the OxiplexTS200. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Iss Medical, Inc. (Champaign, US). The FDA issued a Cleared decision on March 1, 2024, 205 days after receiving the submission on August 9, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K232385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2023 |
| Decision Date | March 01, 2024 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MUD - Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |