The following data is part of a premarket notification filed by Longnan Renzhong Medical Equipment Co., Ltd. with the FDA for Infrared Body Thermometer (model: Yk-001).
| Device ID | K210118 |
| 510k Number | K210118 |
| Device Name: | INFRARED BODY THERMOMETER (Model: YK-001) |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Longnan RenZhong Medical Equipment Co., Ltd. Information Industry Technology City, Longnan Economic Development Zone, Longnan Ganzhou, CN |
| Contact | Liangping Liao |
| Correspondent | Iris Fung SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, SCIENTECH Park Guangzhou Economic & Technology Development 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 | 2021-01-19 |
| Decision Date | 2021-09-15 |