Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K181215 |
Device Name |
Infrared Thermometer |
Applicant |
Shenzhen Finicare Co., Ltd. |
Room201, A Building NO. 1 Qianwan Road |
Shengang Cooperative Zone, Qianhai |
Shenzhen,
CN
518052
|
|
Applicant Contact |
Chao Li |
Correspondent |
Shenzhen Finicare Co., Ltd. |
Room201, A Building NO. 1 Qianwan Road |
Shengang Cooperative Zone, Qianhai |
Shenzhen,
CN
518052
|
|
Correspondent Contact |
Chao Li |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 05/07/2018 |
Decision Date | 01/02/2019 |
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
|
|
|