The following data is part of a premarket notification filed by Shenzhen Combei Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer.
| Device ID | K202741 |
| 510k Number | K202741 |
| Device Name: | Infrared Forehead Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen Combei Technology Co., Ltd. No. 105, Huanguan South Road, Dahe Community, Guanlan, Long Hua New Distri Shenzhen, CN 518110 |
| Contact | Kevin Fong |
| 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 | 2020-09-18 |
| Decision Date | 2021-07-07 |