The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Omni-trac Modification.
| Device ID | K935020 |
| 510k Number | K935020 |
| Device Name: | OMNI-TRAC MODIFICATION |
| Classification | Monitor, St Segment With Alarm |
| Applicant | INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Roger Susi |
| Correspondent | Roger Susi INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-20 |
| Decision Date | 1995-04-26 |