KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K080326
Device Name KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
Applicant
ANDON HEALTH CO.,LTD
no. 10 jinping road
yaan road nankai district
tiajin, 

CN

300190

Correspondent
ANDON HEALTH CO.,LTD
no. 10 jinping road
yaan road nankai district
tiajin, 

CN

300190

Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 02/06/2008
Decision Date 07/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No