The following data is part of a premarket notification filed by Shenzhen Xunwei Industrial Co., Ltd. with the FDA for Infrared Thermometer.
| Device ID | K201579 |
| 510k Number | K201579 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Xunwei Industrial Co., Ltd. First Floor To Fourth, Upper Small Industrial Zone, Jinhua Road, Block 75, Xixiang Shenzhen, CN 518102 |
| Contact | Liu Shengcai |
| Correspondent | Yoyo Chen Shenzhen Joyantech Consulting Co.,Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town 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 | 2020-06-11 |
| Decision Date | 2021-01-15 |