ABL835 FLEX ANALYZER WITH PLEURAL PH


Device Classification Name

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

510(k) Number K110416
Device Name ABL835 FLEX ANALYZER WITH PLEURAL PH
Applicant
RADIOMETER MEDICAL APS
aakandevej 21
broenshoejy, 

DK

dk-2700

Applicant Contact soren bogestrand
Correspondent
RADIOMETER MEDICAL APS
aakandevej 21
broenshoejy, 

DK

dk-2700

Correspodent Contact soren bogestrand
Regulation Number 862.1120
Classification Product Code
CHL  
Date Received 02/14/2011
Decision Date 03/24/2011
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