The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for System Athena, Type 9266 Sa02, Modification.
| Device ID | K911761 |
| 510k Number | K911761 |
| Device Name: | SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION |
| Classification | Oximeter |
| 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 | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-22 |
| Decision Date | 1991-10-31 |