The following data is part of a premarket notification filed by Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. with the FDA for Yuwell Infrared Thermometer.
| Device ID | K201864 |
| 510k Number | K201864 |
| Device Name: | YUWELL Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Yunyang Industrial Park, Danyang, Jiangsu, China Danyang, CN 212300 |
| Contact | Caixia Yang |
| Correspondent | Caixia Yang Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. Yunyang Industrial Park, Danyang, Jiangsu, China Danyang, 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 | 2020-07-06 |
| Decision Date | 2020-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885380191891 | K201864 | 000 |