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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 K142898
Device Name ABL800 FLEX with AQURE connectivity
Applicant
Radiometer Medical Aps
Aakandevej 21
Dk-Bronshoj,  DK 2700
Applicant Contact Lasse Post Moller
Correspondent
Radiometer Medical Aps
Aakandevej 21
Dk-Bronshoj,  DK 2700
Correspondent Contact Lasse Post Moller
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGL   CGZ   CIG  
GHS   GKR   JFP   JGS   KHP   KQI  
MQM  
Date Received10/06/2014
Decision Date 06/17/2015
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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