ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K112273
Device Name ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
Applicant
ACCUMED HEALTHCARE (SHANGHAI) INC.
p.o. box 1277
maple valley, 
WA 
98038

Applicant Contact cynthia (cindy) green
Correspondent
ACCUMED HEALTHCARE (SHANGHAI) INC.
p.o. box 1277
maple valley, 
WA 
98038

Correspodent Contact cynthia (cindy) green
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 08/08/2011
Decision Date 11/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No