The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Arrhythmia 9215.
| Device ID | K900366 |
| 510k Number | K900366 |
| Device Name: | ARRHYTHMIA 9215 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Lisbeth Isbrandt |
| Correspondent | Lisbeth Isbrandt S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-26 |
| Decision Date | 1991-04-26 |