Device Classification Name |
Thermometer, Electronic, Clinical
|
510(k) Number |
K153146 |
Device Name |
Infrared Ear Thermometer |
Applicant |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
BUILDING 2, NO. 202, ZHENZHONG ROAD, |
WEST LAKE ECONOMY & TECHNOLOGY ZONE |
HANGZHOU,
CN
310030
|
|
Applicant Contact |
REN YUNHUA |
Correspondent |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
BUILDING 2, NO. 202, ZHENZHONG ROAD, |
WEST LAKE ECONOMY & TECHNOLOGY ZONE |
HANGZHOU,
CN
310030
|
|
Correspondent Contact |
REN YUNHUA |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 10/30/2015 |
Decision Date | 03/31/2016 |
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
|
|
|