The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Mod. Type 9230 Temp 1 And Temp 2 System Athena.
| Device ID | K915633 |
| 510k Number | K915633 |
| Device Name: | MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA |
| Classification | Thermometer, Electronic, Clinical |
| 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 | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1993-06-29 |