The following data is part of a premarket notification filed by Catalyst Research Corp. with the FDA for Mini Ox Iii Oxygen Monitor.
Device ID | K833326 |
510k Number | K833326 |
Device Name: | MINI OX III OXYGEN MONITOR |
Classification | Algesimeter, Manual |
Applicant | CATALYST RESEARCH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BXL |
CFR Regulation Number | 868.1030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-27 |
Decision Date | 1983-11-03 |