Device Classification Name |
Pump, Breast, Powered
|
510(k) Number |
K211024 |
Device Name |
Electric Breast Pump |
Applicant |
Shantou Huihengqi Electronic Technology Co., Ltd. |
501, 5/F, Block C, 14A Industrial Zone, Longhu District |
Shantou,
CN
515000
|
|
Applicant Contact |
Gensong Yang |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 04/06/2021 |
Decision Date | 02/11/2022 |
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
|
|
|