The following data is part of a premarket notification filed by Catalyst Research Corp. with the FDA for Mini Ox Ii.
| Device ID | K833995 |
| 510k Number | K833995 |
| Device Name: | MINI OX II |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | CATALYST RESEARCH CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-21 |
| Decision Date | 1983-12-12 |