The following data is part of a premarket notification filed by Heitaida Technology Co., Ltd. with the FDA for Non-contact Infrared Body Thermometer, Model Htd8808c, Htd8818a, Htd8816c.
| Device ID | K203332 |
| 510k Number | K203332 |
| Device Name: | Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HeiTaiDa Technology Co., Ltd. 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town Dongguan City, CN 523820 |
| Contact | Tom Chen |
| Correspondent | Karen Ren HeiTaiDa Technology Co., Ltd. 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town Dongguan City, CN 523820 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10681131405895 | K203332 | 000 |
| 16970289035394 | K203332 | 000 |
| 16970289035523 | K203332 | 000 |
| 16970289035578 | K203332 | 000 |
| 16970289035592 | K203332 | 000 |
| 16970289035585 | K203332 | 000 |
| 16970289035714 | K203332 | 000 |
| 00810008218013 | K203332 | 000 |
| 00810008217993 | K203332 | 000 |