The following data is part of a premarket notification filed by Vioptix, Inc. with the FDA for Intra.ox Handheld Tissue Oximeter.
| Device ID | K163472 |
| 510k Number | K163472 |
| Device Name: | Intra.Ox Handheld Tissue Oximeter |
| Classification | Oximeter, Tissue Saturation |
| Applicant | VIOPTIX, INC. 39655 EUREKA DRIVE Newark, CA 94560 |
| Contact | Mark Lonsinger |
| 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 | 2016-12-12 |
| Decision Date | 2017-11-16 |
| Summary: | summary |