The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Omni-trak Model 3150 Series Patient Monitoring System.
| Device ID | K971840 |
| 510k Number | K971840 |
| Device Name: | OMNI-TRAK MODEL 3150 SERIES PATIENT MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-19 |
| Decision Date | 1998-03-04 |