Device Classification Name |
Transducer, Blood-Pressure, Extravascular
|
510(k) Number |
K152472 |
Device Name |
Disposable Pressure Transducer |
Applicant |
ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. |
305#TANGGONG ROAD, PAOJIANG INDUSTRIAL ZONE |
SHAOXING,
CN
312071
|
|
Applicant Contact |
Junbin Hu |
Correspondent |
MEDWHEAT (SHANGHAI) MEDICAL TECHNOLOGY CO.,LTD.. |
YANGPU DISTRIST LIAOYUAN EAST ROAD SHUANGYANG |
FIRST SUITE NO.33 ROOM 303 |
SHANGHAI,
CN
200093
|
|
Correspondent Contact |
Jonathan Hu |
Regulation Number | 870.2850
|
Classification Product Code |
|
Date Received | 08/31/2015 |
Decision Date | 10/31/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|