LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE


Device Classification Name

control, pump speed, cardiopulmonary bypass

510(k) Number K081221
Device Name LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
Applicant
LEVITRONIX LLC.
45 first ave.
waltham, 
MA 
02451

Applicant Contact susan hamann
Correspondent
LEVITRONIX LLC.
45 first ave.
waltham, 
MA 
02451

Correspodent Contact susan hamann
Regulation Number 870.4380
Classification Product Code
DWA  
Date Received 04/30/2008
Decision Date 06/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No