ABL90


Device Classification Name

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

510(k) Number K111897
Device Name ABL90
Applicant
RADIOMETER MEDICAL APS
aakandevej 21
copenhagen, 

DK

2100

Applicant Contact martin gabler
Correspondent
RADIOMETER MEDICAL APS
aakandevej 21
copenhagen, 

DK

2100

Correspodent Contact martin gabler
Regulation Number 862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKR  
JFP   JGS   JIX   JJY   KHP   KQI  
Date Received 07/05/2011
Decision Date 07/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls