Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K152640 |
Device Name |
Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) |
Applicant |
FUDAKANG INDUSTRIES CO., LTD |
NO.8 YINGHE ROAD, YUANJIANGYUAN |
MANAGEMENT ZONE, CHANGPING TOWN |
DONGGUAN,
CN
523560
|
|
Applicant Contact |
BOB YU |
Correspondent |
SHENZHEN JOYANTECH CONSULTING CO., LTD. |
2032#, INTERNATIONAL MAYOR COMMUNICATION CENTER, |
SHIZHOU ZHONG ROAD 55#, NA |
SHENZHEN,
CN
518100
|
|
Correspondent Contact |
FIELD FU |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 09/15/2015 |
Decision Date | 03/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|