Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K180385 |
Device Name |
Infrared Body Thermometer |
Applicant |
HeTaiDa Technology Co., Ltd. |
4F, BaiShiDa High-Tech Park, XiangDong Industrial Area |
DaLingShan Town |
DongGuan City,
CN
523820
|
|
Applicant Contact |
Tom Chen |
Correspondent |
Qimmiq Medical Consulting Service Co., Ltd. |
RM.1711, Building K, NO.101 Science Ave International |
Creative Valley |
Guangzhou,
CN
510663
|
|
Correspondent Contact |
You Yijie |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 02/12/2018 |
Decision Date | 05/11/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|