Device Classification Name |
thermometer, electronic, clinical
|
510(k) Number |
K181081 |
Device Name |
Infrared Ear Thermometer |
Applicant |
Joytech Healthcare Co., Ltd. |
No.365, Wuzhou Road, Yuhang Economic Development Zone |
Hangzhou City |
Hangzhou,
CN
311100
|
|
Applicant Contact |
Ren Yunhua |
Correspondent |
Joytech Healthcare Co., Ltd. |
No.365, Wuzhou Road, Yuhang Economic Development Zone |
Hangzhou City |
Hangzhou,
CN
311100
|
|
Correspondent Contact |
Ren Yunhua |
Regulation Number | 880.2910
|
Classification Product Code |
|
Date Received | 04/24/2018 |
Decision Date | 10/02/2018 |
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
|
|
|