The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Type 9320 Cardiac Output System Athena.
| Device ID | K884122 |
| 510k Number | K884122 |
| Device Name: | TYPE 9320 CARDIAC OUTPUT SYSTEM ATHENA |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| 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 | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-30 |
| Decision Date | 1989-04-25 |