HEM-7200-Z (BP742)


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K121932
Device Name HEM-7200-Z (BP742)
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 07/02/2012
Decision Date 08/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No