K163472 is an FDA 510(k) clearance for the Intra.Ox 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 November 16, 2017, 339 days after receiving the submission on December 12, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2700.
| 510(k) Number | K163472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2016 |
| Decision Date | November 16, 2017 |
| Days to Decision | 339 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MUD - Oximeter, Tissue Saturation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2700 |