The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type 9210 S/ecg.
| Device ID | K903940 |
| 510k Number | K903940 |
| Device Name: | TYPE 9210 S/ECG |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Mette Jorgensen |
| Correspondent | Mette Jorgensen 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 | 1990-08-27 |
| Decision Date | 1991-12-04 |