Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K162338 |
Device Name |
Full Automatic (NIBP) Blood Pressure Monitor |
Applicant |
HEALTH & LIFE CO., LTD. |
9F, NO.186, JIAN YI ROAD |
ZHONGHE DISTRICT, NEW TAIPEI CITY,
TW
23553
|
|
Applicant Contact |
SARAH SU |
Correspondent |
HEALTH & LIFE CO., LTD. |
9F, NO.186, JIAN YI ROAD |
ZHONGHE DISTRICT, NEW TAIPEI CITY,
TW
23553
|
|
Correspondent Contact |
SARAH SU |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 08/22/2016 |
Decision Date | 09/21/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|