The following data is part of a premarket notification filed by Shenzhen Sonida Digital Technology Co., Ltd with the FDA for Infrared Thermometer.
| Device ID | K202440 |
| 510k Number | K202440 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Sonida Digital Technology Co., Ltd 6F./3F-B., Building B, Zhengchangda Technopark, Tangwei Jianan Road, Fuhai Shenzhen, CN 518103 |
| Contact | Vivi Wey |
| 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 | 2020-08-25 |
| Decision Date | 2021-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972901150211 | K202440 | 000 |
| 06972901150204 | K202440 | 000 |
| 06972901150198 | K202440 | 000 |
| 06972901150006 | K202440 | 000 |