ALPHA OMEGA DUAL COOLER-HEATER


information about

Device Classification Name

controller, temperature, cardiopulmonary bypass

510(k) Number K001520
Device Name ALPHA OMEGA DUAL COOLER-HEATER
Original Applicant
ALPHA OMEGA, INC.
2525 hartford rd.
austin, 
TX 
78703

Original Contact richard martin
Regulation Number 870.4250
Classification Product Code
DWC  
Date Received 05/16/2000
Decision Date 11/22/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party No

Combination Product

No