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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K122642
Device Name ABL90 FLEX
Original Applicant
RADIOMETER MEDICAL APS
akandevej 21
bronshoj,  DA dk-2700
Original Contact martin gabler
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKR  
JFP   JGS   JIX   JJY   KHP   KQI  
Date Received08/29/2012
Decision Date 10/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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