The following data is part of a premarket notification filed by Jiaxing Shangjia Intelligence Technology Co., Ltd. with the FDA for Infrared Forehead Thermometer, Model: Hs-9802d.
| Device ID | K213038 |
| 510k Number | K213038 |
| Device Name: | Infrared Forehead Thermometer, Model: HS-9802D |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Jiaxing Shangjia Intelligence Technology Co., Ltd. Room 102 & 202, Building No. 9, Jiaxing Intelligence & Innovation Park, No. 36 Jiaxing, CN 314000 |
| Contact | Lou Yongwei |
| Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, CN 510663 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-21 |
| Decision Date | 2022-03-10 |