K191676 is an FDA 510(k) clearance for the Intra.Ox 2.0 Handheld Tissue Oximeter, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Vioptix, Inc. (Newark, US). The FDA issued a Cleared decision on September 16, 2019, 84 days after receiving the submission on June 24, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K191676 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 24, 2019 |
| Decision Date | September 16, 2019 |
| Days to Decision | 84 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 |