The following data is part of a premarket notification filed by Analogic Corp. with the FDA for Siemens Sirecust Models 403p,403-2p & 403n.
| Device ID | K855096 |
| 510k Number | K855096 |
| Device Name: | SIEMENS SIRECUST MODELS 403P,403-2P & 403N |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-07-15 |