The following data is part of a premarket notification filed by Vioptix, Inc. with the FDA for Odissey Tissue Oximeter.
| Device ID | K141234 |
| 510k Number | K141234 |
| Device Name: | ODISSEY TISSUE OXIMETER |
| Classification | Oximeter, Tissue Saturation |
| Applicant | VIOPTIX, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Greg Holland |
| Correspondent | Greg Holland VIOPTIX, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | MUD |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-13 |
| Decision Date | 2014-07-01 |
| Summary: | summary |