The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Tcpo2 9260 Module - System Athena.
| Device ID | K913013 |
| 510k Number | K913013 |
| Device Name: | TCPO2 9260 MODULE - SYSTEM ATHENA |
| Classification | Monitor, Carbon-dioxide, Cutaneous |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Morten Nielson |
| Correspondent | Morten Nielson S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | LKD |
| CFR Regulation Number | 868.2480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-08 |
| Decision Date | 1994-05-03 |