The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Piccolo/exato Infared Ear Thermometer (ts2 & Ts4 Series).
| Device ID | K010462 |
| 510k Number | K010462 |
| Device Name: | AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | AVITA CORPORATION 900 N. SWITZER CANYON DR. #142 Flaggstaff, AZ 86001 |
| Contact | Allen Reich |
| Correspondent | Allen Reich AVITA CORPORATION 900 N. SWITZER CANYON DR. #142 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 | 2001-02-16 |
| Decision Date | 2001-04-11 |