The following data is part of a premarket notification filed by Wenzhou Yosun Medical Technology Co., Ltd. with the FDA for Infrared Ear And Forehead Thermometer, Model Yi-100.
| Device ID | K201843 |
| 510k Number | K201843 |
| Device Name: | Infrared Ear And Forehead Thermometer, Model YI-100 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Wenzhou Yosun Medical Technology Co., Ltd. No. 17, Shahong Road, Lingmen, Beibaixiang Town, Yueqing Wenzhou, CN 325603 |
| Contact | Lihao Yang |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1813#, Gebu Commerical Building, Hongxing Community, Songgang Street Shenzhen, CN 518000 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-06 |
| Decision Date | 2020-10-23 |