EV1000 CLINICAL PLATFORM


Device Classification Name

computer, diagnostic, pre-programmed, single-function

510(k) Number K110597
Device Name EV1000 CLINICAL PLATFORM
Applicant
EDWARDS LIFESCIENCES
one edwards way
irvine, 
CA 
92614

Applicant Contact marguerite thomlinson
Correspondent
EDWARDS LIFESCIENCES
one edwards way
irvine, 
CA 
92614

Correspodent Contact marguerite thomlinson
Regulation Number 870.1435
Classification Product Code
DXG  
Date Received 03/02/2011
Decision Date 06/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No