The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Siemens Sirecust Penta System And Accessories.
| Device ID | K920445 |
| 510k Number | K920445 |
| Device Name: | SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-04 |
| Decision Date | 1993-03-02 |