The following data is part of a premarket notification filed by S & W Medico Teknik A/s with the FDA for 3050 Diascope Nt Patient Monitor.
| Device ID | K942196 |
| 510k Number | K942196 |
| Device Name: | 3050 DIASCOPE NT PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | S & W MEDICO TEKNIK A/S HERSTEDVANG 8 Albertslund, DK Dk-2620 |
| Contact | Morten Nielsen |
| Correspondent | Morten Nielsen S & W MEDICO TEKNIK A/S HERSTEDVANG 8 Albertslund, DK Dk-2620 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-04 |
| Decision Date | 1995-06-28 |