Device Classification Name |
Device, Counter-Pulsating, External
|
510(k) Number |
K191955 |
Device Name |
Enhanced External Counter Pulsation Device Plus Omay-A |
Applicant |
Omay(Guangzhou)Med Technologies Co., Ltd. |
Room 302,3F, No. 600-1, Guangshan 2nd Road, Tianhe |
Guangzhou,
CN
|
|
Applicant Contact |
Peixian Su |
Correspondent |
Chonconn Medical Device Consulting Co., Ltd. |
No. A415, Block A, NanShan Medical Devices Industrial Park |
Nanshan District |
Shenzhen,
CN
518067
|
|
Correspondent Contact |
Kevin Wang |
Regulation Number | 870.5225
|
Classification Product Code |
|
Date Received | 07/22/2019 |
Decision Date | 08/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|