The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Ts8/ts9 Series Ir Ear/forehead Thermometer.
| Device ID | K031503 |
| 510k Number | K031503 |
| Device Name: | AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | AVITA CORPORATION 3892 SOUTH AMERICA WEST TRAIL, Flaggstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich AVITA CORPORATION 3892 SOUTH AMERICA WEST TRAIL, Flaggstaff, AZ 86001 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-13 |
| Decision Date | 2003-10-24 |
| Summary: | summary |