The following data is part of a premarket notification filed by Guandong Genial Technology Co., Limited with the FDA for Infrared Forehead Thermometer (model: T80, T81, T82, T83, T84, T85).
| Device ID | K210014 |
| 510k Number | K210014 |
| Device Name: | Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Guandong Genial Technology CO., LIMITED I-6-05-02, 11th Road, Area B, Guangfozhao Economic Cooperation Zone, Zhagang Town Zhaoqing, CN |
| Contact | Jun Yu |
| Correspondent | Jet Li Guangzhou KINDA Biology Technology Co., Ltd. 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-04 |
| Decision Date | 2021-06-04 |