The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Omni-trak (patient Monitor).
| Device ID | K890817 |
| 510k Number | K890817 |
| Device Name: | OMNI-TRAK (PATIENT MONITOR) |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | INVIVO RESEARCH, INC. 11800 RESEARCH PKWY. SUITE A Orlando, FL 32826 |
| Contact | Tom W Foshee |
| Correspondent | Tom W Foshee INVIVO RESEARCH, INC. 11800 RESEARCH PKWY. SUITE A Orlando, FL 32826 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-17 |
| Decision Date | 1989-08-10 |