HEM-4030


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K110501
Device Name HEM-4030
Applicant
OMRON HEALTHCARE, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
OMRON HEALTHCARE, INC.
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 02/22/2011
Decision Date 03/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No