Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K152003 |
Device Name |
iHealth BP3L Wireless Blood Pressure Monitor |
Applicant |
ANDON HEALTH CO.,LTD |
NO 3, JINPING STREET, YA AN ROAD |
NANKAI DISTRICT |
TIANJIN,
CN
300190
|
|
Applicant Contact |
Liu Yi |
Correspondent |
ANDON HEALTH CO.,LTD |
NO 3, JINPING STREET, YA AN ROAD |
NANKAI DISTRICT |
TIANJIN,
CN
300190
|
|
Correspondent Contact |
Liu Yi |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 07/20/2015 |
Decision Date | 09/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|