Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K171214 |
Device Name |
Infrared Thermometer |
Applicant |
Shenzhen Brav Electronic Technologies Co., Ltd. |
4/F, Block 11, Tongfuyu Industrial District |
Huangmabu, Xixiang, Bao'an |
Shenzhen,
CN
518102
|
|
Applicant Contact |
Aaron Wan |
Correspondent |
Shenzhen Brav Electronic Technologies Co., Ltd. |
4/F, Block 11, Tongfuyu Industrial District |
Huangmabu, Xixiang, Bao'an |
Shenzhen,
CN
518102
|
|
Correspondent Contact |
Ivy Chen |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 04/25/2017 |
Decision Date | 03/02/2018 |
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
|
|
|