TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM


Device Classification Name

computer, diagnostic, pre-programmed, single-function

510(k) Number K080116
Device Name TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM
Applicant
TRANSONIC SYSTEMS, INC.
34 dutch mill rd.
ithaca, 
NY 
14850

Applicant Contact mark s alsberge
Correspondent
TRANSONIC SYSTEMS, INC.
34 dutch mill rd.
ithaca, 
NY 
14850

Correspodent Contact mark s alsberge
Regulation Number 870.1435
Classification Product Code
DXG  
Date Received 01/16/2008
Decision Date 09/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls