Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K150430 |
Device Name |
Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor |
Applicant |
FUDAKANG INDUSTRIAL CO., LTD |
NO 8 YINGHE ROAD, YUANJIANGYUAN |
MANAGEMENT ZONE, CHANGPING TOWN |
DONGGUAN,
CN
523560
|
|
Applicant Contact |
BOB YU |
Correspondent |
SHENZHEN JOYANTECH CONSULTING CO., LTD. |
4TH FLOOR, JINHUI BUILDING NANHAI BLVD, NANSHAN DISTRICT |
SHENZHEN,
CN
518100
|
|
Correspondent Contact |
MR. FIELD FU |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 02/19/2015 |
Decision Date | 04/17/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|