The following data is part of a premarket notification filed by Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer.
| Device ID | K201536 |
| 510k Number | K201536 |
| Device Name: | Infrared Forehead Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Hangzhou Qingyuan Medical Equipment Technology Co., Ltd. No.688 Dong'an 1st Road, Xintang Street, Xaioshan District Hangzhou, CN 311200 |
| Contact | Jenny Li |
| 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 | 2020-06-08 |
| Decision Date | 2021-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973150480453 | K201536 | 000 |