The following data is part of a premarket notification filed by Heitaida Technology Co., Ltd. with the FDA for Infrared Body Thermometer.
Device ID | K200781 |
510k Number | K200781 |
Device Name: | Infrared Body Thermometer |
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 | 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 | 2020-03-11 |
Decision Date | 2020-12-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
16970289035202 | K200781 | 000 |
06970289035175 | K200781 | 000 |
16970289035356 | K200781 | 000 |
16970289035349 | K200781 | 000 |
16970289035431 | K200781 | 000 |