The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Sirecust 730, Patient Monitor W/arrhythmia.
| Device ID | K894460 |
| 510k Number | K894460 |
| Device Name: | SIEMENS SIRECUST 730, PATIENT MONITOR W/ARRHYTHMIA |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | SIEMENS MEDICAL ELECTRONICS 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Robert R Murfitt |
| Correspondent | Robert R 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 | 1989-07-18 |
| Decision Date | 1989-10-02 |