The following data is part of a premarket notification filed by Vioptix, Inc. with the FDA for Intra.ox 2.0 Handheld Tissue Oximeter.
| Device ID | K191676 |
| 510k Number | K191676 |
| Device Name: | Intra.Ox 2.0 Handheld Tissue Oximeter |
| Classification | Oximeter, Tissue Saturation |
| Applicant | ViOptix, Inc. 39655 Eureka Drive Newark, CA 94560 |
| Contact | Scott Coleridge |
| Correspondent | Valerie Defiesta-ng Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-24 |
| Decision Date | 2019-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B426OXY2STH10 | K191676 | 000 |
| B426OXY2QCT10 | K191676 | 000 |
| B426OXY2DUR10 | K191676 | 000 |