The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort-link Arrhythmia Option 23l.
| Device ID | K915153 |
| 510k Number | K915153 |
| Device Name: | ESCORT-LINK ARRHYTHMIA OPTION 23L |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | Jim Rooks |
| Correspondent | Jim Rooks 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 | 1991-11-14 |
| Decision Date | 1992-04-27 |