The following data is part of a premarket notification filed by Hetaida Technology Co., Ltd. with the FDA for Non-contact Infrared Body Thermometer, Model:htd8823us.
| Device ID | K200159 |
| 510k Number | K200159 |
| Device Name: | Non-contact Infrared Body Thermometer, Model:HTD8823US |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HeTaiDa Technology Co., Ltd. 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town Dongguan City, CN 523820 |
| Contact | Tom Chen |
| 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 | 2020-01-22 |
| Decision Date | 2021-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16970289035196 | K200159 | 000 |
| 16970289035240 | K200159 | 000 |
| 16970289035516 | K200159 | 000 |
| 16970289035622 | K200159 | 000 |