The following data is part of a premarket notification filed by Siemens Medical Electronics with the FDA for Sirecust 1280/1281 & 960/961 Patient Monitors.
| Device ID | K881939 |
| 510k Number | K881939 |
| Device Name: | SIRECUST 1280/1281 & 960/961 PATIENT MONITORS |
| Classification | Electrocardiograph |
| 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 | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-09 |
| Decision Date | 1988-07-18 |