The following data is part of a premarket notification filed by Vioptix Inc. with the FDA for Intra. Ox Handheld Tissue Oximeter.
| Device ID | K133983 |
| 510k Number | K133983 |
| Device Name: | INTRA. OX HANDHELD 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 | 2013-12-27 |
| Decision Date | 2014-09-12 |
| Summary: | summary |