Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K172894 |
Device Name |
Infrared Thermometer |
Applicant |
Shenzhen Jiacom Technology Co ., Ltd |
No. A6 Building, Silicon Valley Power |
Qinghu Park, Longhua Street, Bao’an Dist |
Shenzhen,
CN
518109
|
|
Applicant Contact |
Luo Tianfeng |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 09/22/2017 |
Decision Date | 05/17/2018 |
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
|
|
|