The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Omni-trak Patient Monitoring System.
| Device ID | K955045 |
| 510k Number | K955045 |
| Device Name: | OMNI-TRAK PATIENT MONITORING SYSTEM |
| Classification | Electrocardiograph |
| Applicant | INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Francis X Casey |
| Correspondent | Francis X Casey INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-03 |
| Decision Date | 1996-07-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838016002 | K955045 | 000 |
| 20884838029525 | K955045 | 000 |