Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K191570 |
Device Name |
Infrared Thermometer Model MD-H30 |
Applicant |
Guangzhou Berrcom Medical Device Co., Ltd. |
No.38 Huanzhen Xi Road, Dagang Town, Nansha |
Guangzhou,
CN
511470
|
|
Applicant Contact |
Zhigang Du |
Correspondent |
Shenzhen Joyantech Consulting Co., Ltd |
NO. 55 Shizhou middle road, Nanshan District |
Shenzhen,
CN
518000
|
|
Correspondent Contact |
Christy Young |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 06/13/2019 |
Decision Date | 11/13/2019 |
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
|
|
|