1500 PRO


Device Classification Name

system, measurement, blood-pressure, non-invasive

510(k) Number K080289
Device Name 1500 PRO
Applicant
OMRON HEALTHCARE, INC.
3460 pointe creek court #102
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
OMRON HEALTHCARE, INC.
3460 pointe creek court #102
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 870.1130
Classification Product Code
DXN  
Date Received 02/04/2008
Decision Date 02/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No