The following data is part of a premarket notification filed by Analogic Corp. with the FDA for System Sirecust 400 Siemens Sirecust 456-1a.
| Device ID | K844791 |
| 510k Number | K844791 |
| Device Name: | SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Contact | Marvin Rosenbaum |
| Correspondent | Marvin Rosenbaum ANALOGIC CORP. 8 CENTENNIAL DR. Peabody, MA 01960 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-10 |
| Decision Date | 1985-04-10 |