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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 K131988
Device Name ABL90 FLEX ANALYZER
Applicant
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Applicant Contact GITTE JUEL FRIIS
Correspondent
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Correspondent Contact GITTE JUEL FRIIS
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKR  
JFP   JGS   JIX   JJY   KHP   KQI  
Date Received06/28/2013
Decision Date 09/17/2013
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
Predetermined Change
Control Plan Authorized		 No
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