The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for System Athena - Product Enhancements.
| Device ID | K912049 |
| 510k Number | K912049 |
| Device Name: | SYSTEM ATHENA - PRODUCT ENHANCEMENTS |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| 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 | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-09 |
| Decision Date | 1991-12-05 |