The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Scaneo Infrared Ear Thermometer, Model Ts7.
| Device ID | K100016 |
| 510k Number | K100016 |
| Device Name: | AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | AVITA CORPORATION 2904 N. BOLDT DR. Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich AVITA CORPORATION 2904 N. BOLDT DR. Flagstaff, AZ 86001 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-04 |
| Decision Date | 2010-03-04 |