FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112320
Device Name FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR
Applicant
HEALTH & LIFE CO., LTD.
9f, no.186, jian yi road
chung ho city, taipei, 

TW

235

Applicant Contact sarah su
Correspondent
HEALTH & LIFE CO., LTD.
9f, no.186, jian yi road
chung ho city, taipei, 

TW

235

Correspodent Contact sarah su
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 08/11/2011
Decision Date 09/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No