Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K171888 |
Device Name |
Non-contact infrared body thermometer |
Applicant |
Hetaida Technology Co., Ltd |
4F, BaiShiDa High-Tech Park, XianDong Industrial Area, |
DaLingShan |
DongGuan,
CN
523820
|
|
Applicant Contact |
ZhenGuang Chen |
Correspondent |
Elliiot Medical Solutions |
18586 Parkland Drive |
Shaker Heights,
OH
44122
|
|
Correspondent Contact |
Roman Huang |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 06/26/2017 |
Decision Date | 07/23/2018 |
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
|
|
|