BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112647
Device Name BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
Applicant
WISTRON CORPORATION
3f, 5f, no 127, wugong 2nd rd
wugu district
new taipei city, 

TW

24888

Applicant Contact teling hsu
Correspondent
WISTRON CORPORATION
3f, 5f, no 127, wugong 2nd rd
wugu district
new taipei city, 

TW

24888

Correspodent Contact teling hsu
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 09/12/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No