The following data is part of a premarket notification filed by Vioptix, Inc. with the FDA for Vioptix Odissey Tissue Oximeter Tissue Oximeter, Model Oxy-2.
| Device ID | K042657 |
| 510k Number | K042657 |
| Device Name: | VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 |
| 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 | 2004-09-28 |
| Decision Date | 2005-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B426OXY2SPI10 | K042657 | 000 |
| B426OXY2SPD10 | K042657 | 000 |