The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Link Central Station Monitor.
| Device ID | K970012 |
| 510k Number | K970012 |
| Device Name: | ESCORT LINK CENTRAL STATION MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | David Trueblood |
| Correspondent | David Trueblood MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-02 |
| Decision Date | 1997-06-26 |
| Summary: | summary |