K221010 is an FDA 510(k) clearance for the Intra.Ox 2.0 Handheld Tissue Oximeter. This device is classified as a Oximeter, Tissue Saturation (Class II - Special Controls, product code MUD).
Submitted by Vioptix, Inc. (Newark, US). The FDA issued a Cleared decision on May 3, 2022, 28 days after receiving the submission on April 5, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K221010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2022 |
| Decision Date | May 03, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| 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 |