HEALTHTRACKER


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K110770
Device Name HEALTHTRACKER
Applicant
WISTRON CORPORATION
6th floor no 127 wugong 2nd rd
wugu township
taipei county, 

TW

24888

Applicant Contact teling hsu
Correspondent
WISTRON CORPORATION
6th floor no 127 wugong 2nd rd
wugu township
taipei county, 

TW

24888

Correspodent Contact teling hsu
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 03/18/2011
Decision Date 11/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No