Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K120672 |
Device Name |
KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR |
Applicant |
ANDON HEALTH CO.,LTD |
116 VILLAGE BOULEVARD |
SUITE 200 |
princeton,
NJ
08540
|
|
Applicant Contact |
thomas becze |
Correspondent |
ANDON HEALTH CO.,LTD |
116 VILLAGE BOULEVARD |
SUITE 200 |
princeton,
NJ
08540
|
|
Correspondent Contact |
thomas becze |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 03/05/2012 |
Decision Date | 06/01/2012 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Special
|
Clinical Trials |
NCT01575067
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|