The following data is part of a premarket notification filed by Hunan Honggao Electronic Technolofy Co., Ltd. with the FDA for Medical Infrared Forehead Thermometer.
| Device ID | K202111 |
| 510k Number | K202111 |
| Device Name: | Medical Infrared Forehead Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Hunan Honggao Electronic Technolofy Co., Ltd. Block 5, Tenghui Pioneer Park, Nanxian Economic Development Yiyang, CN 413200 |
| Contact | Rongfang Hu |
| Correspondent | Jet Li Guangzhou Kinda Biological 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 | 2020-07-30 |
| Decision Date | 2021-02-26 |