WITHINGS BLOOD PRESSURE MONITOR


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

Correspodent Contact jen ke-min
Regulation Number 870.1130
Classification Product Code
DXN  
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