The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Scaneo Ir Thermometer, Models Ts2x & Ts3x Series.
| Device ID | K092958 |
| 510k Number | K092958 |
| Device Name: | AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES |
| 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 | 2009-09-25 |
| Decision Date | 2009-12-02 |
| Summary: | summary |