Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K180314 |
Device Name |
Infrared Thermometer |
Applicant |
Xuzhou Yongkang Electronic Science Technology Co., Ltd |
4F Building C8,40 Jingshan Road |
Econonic and Technolgical Development Zone |
Xuzhou,
CN
102628
|
|
Applicant Contact |
Xuecheng Zhao |
Correspondent |
Beijing Believe-Med Technology Service Co., Ltd. |
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., |
FangShan District |
Beijing,
CN
102401
|
|
Correspondent Contact |
Ray Wang |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 02/05/2018 |
Decision Date | 07/11/2018 |
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
|
|
|