Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K110872 |
Device Name |
WITHINGS BLOOD PRESSURE MONITOR |
Applicant |
WITHINGS |
NO.58, FU CHIUN STREET |
HSIN CHU CITY,
TW
30067
|
|
Applicant Contact |
JEN KE-MIN |
Correspondent |
WITHINGS |
NO.58, FU CHIUN STREET |
HSIN CHU CITY,
TW
30067
|
|
Correspondent Contact |
JEN KE-MIN |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 03/29/2011 |
Decision Date | 05/20/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|