Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K200802 |
Device Name |
Infrared Thermometer |
Applicant |
Shenzhen Urion Technology Co., Ltd |
4-6F of Building D, Jiale Science& Technology Industrial |
Zone, Heshuikou Comm |
Shenzhen,
CN
518106
|
|
Applicant Contact |
Autumn Liu |
Correspondent |
Shenzhen Reanny Medical Devices Management Consulting Co Ltd |
Room 2012#, Gebu commercial building, Hongxing community, |
Songgang street |
Shenzhen,
CN
518105
|
|
Correspondent Contact |
Changming Zhu |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 03/27/2020 |
Decision Date | 10/07/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|