The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Sirecust 1481t, Digital Telemetry System.
| Device ID | K900319 |
| 510k Number | K900319 |
| Device Name: | SIEMENS SIRECUST 1481T, DIGITAL TELEMETRY SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Robert Murfitt |
| Correspondent | Robert Murfitt SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-23 |
| Decision Date | 1990-06-28 |