The following data is part of a premarket notification filed by Hetaida Technology Co., Ltd. with the FDA for Infrared Body Thermometer.
| Device ID | K180385 |
| 510k Number | K180385 |
| Device Name: | Infrared Body Thermometer |
| 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 | 2018-02-12 |
| Decision Date | 2018-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16970289030009 | K180385 | 000 |
| 16970289035042 | K180385 | 000 |
| 16970289035271 | K180385 | 000 |
| 16970289035264 | K180385 | 000 |
| 16970289035301 | K180385 | 000 |
| 16970289035318 | K180385 | 000 |
| 16970289035455 | K180385 | 000 |
| 16970289035462 | K180385 | 000 |