APPS-HEALTH01


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K122098
Device Name APPS-HEALTH01
Applicant
ANDON HEALTH CO., LTD
no. 3 jin ping street,ya an road,
nankai district
tianjin, 

CN

300190

Applicant Contact yi liu
Correspondent
ANDON HEALTH CO., LTD
no. 3 jin ping street,ya an road,
nankai district
tianjin, 

CN

300190

Correspodent Contact yi liu
Regulation Number 870.1130
Classification Product Code
DXN  
Subsequent Product Code
MNW  
Date Received 07/16/2012
Decision Date 03/21/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No