Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K163136 |
Device Name |
Youha electric breast pump |
Applicant |
NINGBO YOUHE ELECTRICAL APPLIANCE TECHNOLOGY CO.,LTD. |
NO.226-228, SAN JIAO TIAN RD, FU HAI TOWN |
CIXI,
CN
315322
|
|
Applicant Contact |
Huang Yun Jun |
Correspondent |
SHANGHAI QISHENG BUSINESS CONSULTING CO.,LTD. |
ROOM 1301, BLD 46, JING GU ZHONG RD., NO.58, |
MIN HANG DISTRICT, SHANGHAI, CN |
Shanghai,
CN
200240
|
|
Correspondent Contact |
Daniel Qiu |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 11/08/2016 |
Decision Date | 07/31/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|