The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Infrared Therometer With Bluetooth.
| Device ID | K110559 |
| 510k Number | K110559 |
| Device Name: | AVITA INFRARED THEROMETER WITH BLUETOOTH |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-28 |
| Decision Date | 2012-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719878123013 | K110559 | 000 |