The following data is part of a premarket notification filed by Medical Data Electronics with the FDA for Escort Ecg Monitor Siemens Sirecust 466.
| Device ID | K854234 |
| 510k Number | K854234 |
| Device Name: | ESCORT ECG MONITOR SIEMENS SIRECUST 466 |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-21 |
| Decision Date | 1986-01-21 |