Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K133588 |
Device Name |
FORA CARE BLOOD PRESSURE MONITORING SYSTEM |
Applicant |
FORA CARE INC. |
6F, NO.127, WUGONG 2ND RD |
WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Applicant Contact |
Sharon Peng |
Correspondent |
FORA CARE INC. |
6F, NO.127, WUGONG 2ND RD |
WUGU DISTRICT |
NEW TAIPEI CITY,
TW
24888
|
|
Correspondent Contact |
Sharon Peng |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 11/21/2013 |
Decision Date | 04/25/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|