The following data is part of a premarket notification filed by Avita Corporation with the FDA for Avita Radar Thermo Nt16 Series Ir Thermometer.
| Device ID | K172427 |
| 510k Number | K172427 |
| Device Name: | AViTA Radar Thermo NT16 Series IR Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Avita Corporation 9F, No.78, Sec. 1, Kwang-Fu Road., San-Chung District New Taipei City, TW 24158 |
| Contact | Steven Jhou |
| Correspondent | Steven Jhou Avita Corporation 9F, No.78, Sec. 1, Kwang-Fu Road., San-Chung District New Taipei City, TW 24158 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-10 |
| Decision Date | 2018-04-19 |
| Summary: | summary |