The following data is part of a premarket notification filed by Shenzhen Bsx Technology Electronics Co., Ltd. with the FDA for Infrared Forehead Thermometer, Model Bsx976.
| Device ID | K202296 |
| 510k Number | K202296 |
| Device Name: | Infrared Forehead Thermometer, Model BSX976 |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Shenzhen BSX Technology Electronics Co., Ltd. Rm301.3F 8th Building, LiHao Industrial Area, No.78 AiNan Road Shenzhen, CN 518116 |
| Contact | Lijuan Du |
| Correspondent | Lijuan Du Shenzhen BSX Technology Electronics Co., Ltd. Rm301.3F 8th Building, LiHao Industrial Area, No.78 AiNan Road Shenzhen, CN 518116 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-13 |
| Decision Date | 2021-07-23 |