The following data is part of a premarket notification filed by Invivo Research, Inc. with the FDA for Centurion Central Station Arrhythmia Patient Monitoring System.
| Device ID | K980045 |
| 510k Number | K980045 |
| Device Name: | CENTURION CENTRAL STATION ARRHYTHMIA PATIENT MONITORING SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Francix X Casey |
| Correspondent | Francix X Casey INVIVO RESEARCH, INC. 12601 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-06 |
| Decision Date | 1998-11-16 |
| Summary: | summary |