The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd with the FDA for Yuwell Infrared Ear Thermometer: Yht101, Yht200.
| Device ID | K203583 |
| 510k Number | K203583 |
| Device Name: | YUWELL Infrared Ear Thermometer: YHT101, YHT200 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Yunyang Industrial Park, Danyang, Jiangsu, China Jiangsu, CN 212300 |
| Contact | Yuzhuo Wang |
| Correspondent | Yuzhuo Wang Jiangsu Yuyue Medical Equipment & Supply Co., Ltd Yunyang Industrial Park, Danyang, Jiangsu, China Jiangsu, CN 212300 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-08 |
| Decision Date | 2021-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06933257922082 | K203583 | 000 |