The following data is part of a premarket notification filed by S & W Medico Teknik A/s with the FDA for 9750 Athena Ethernet Option.
| Device ID | K934887 |
| 510k Number | K934887 |
| Device Name: | 9750 ATHENA ETHERNET OPTION |
| Classification | Echocardiograph |
| Applicant | S & W MEDICO TEKNIK A/S HERSTEDVANG 8 Albertslund, DK Dk-2620 |
| Contact | Morten Nielaen |
| Correspondent | Morten Nielaen S & W MEDICO TEKNIK A/S HERSTEDVANG 8 Albertslund, DK Dk-2620 |
| Product Code | DXK |
| CFR Regulation Number | 870.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1994-01-14 |