SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G


Device Classification Name

oxygenator, cardiopulmonary bypass

510(k) Number K023745
Device Name SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G
Original Applicant
SECHRIST INDUSTRIES, INC.
4225 east la palma
anaheim, 
CA 
92807

Original Contact greg godfrey
Regulation Number 870.4350
Classification Product Code
DTZ  
Date Received 11/07/2002
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No