Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K070828 |
Device Name |
KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
Applicant |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
NO.31, CHANGJIANG ROAD, |
NANKAI DISTRICT |
TIANJIN,
CN
300193
|
|
Applicant Contact |
LIU YI |
Correspondent |
KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., |
NO.31, CHANGJIANG ROAD, |
NANKAI DISTRICT |
TIANJIN,
CN
300193
|
|
Correspondent Contact |
LIU YI |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 03/26/2007 |
Decision Date | 08/15/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|