ABL 80 CO-OX SYSTEM


Device Classification Name

electrode measurement, blood-gases (pco2, po2) and blood ph

510(k) Number K080370
Device Name ABL 80 CO-OX SYSTEM
Applicant
SENDX MEDICAL, INC.
1945 palomar oaks way
carlsbad, 
CA 
92011

Applicant Contact mark a dzendzel
Correspondent
SENDX MEDICAL, INC.
1945 palomar oaks way
carlsbad, 
CA 
92011

Correspodent Contact mark a dzendzel
Regulation Number 862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKR  
GLY   JFP   JGS   JIX   JJY   JPI  
Date Received 02/12/2008
Decision Date 07/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls