Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K121470 |
Device Name |
FULLY AUTOMATIC WIRELESS BLOOD PRESSURE WRIST MONITOR |
Applicant |
ANDON HEALTH CO., LTD |
No. 3 Jin Ping Street,Ya An Road, |
NANKAI DISTRICT |
TIANJIN,
CN
300190
|
|
Applicant Contact |
LIU YI |
Correspondent |
ANDON HEALTH CO., LTD |
No. 3 Jin Ping Street,Ya An Road, |
NANKAI DISTRICT |
TIANJIN,
CN
300190
|
|
Correspondent Contact |
LIU YI |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 05/17/2012 |
Decision Date | 06/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|