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 |