The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Model 400t Telemetry Ecg Monitor.
| Device ID | K902254 |
| 510k Number | K902254 |
| Device Name: | ESCORT MODEL 400T TELEMETRY ECG MONITOR |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Contact | Chip Harlow |
| Correspondent | Chip Harlow MEDICAL DATA ELECTRONICS 12720 WENTWORTH ST. Arleta, CA 91331 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1990-07-27 |