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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 K160153
Device Name ABL90 FLEX PLUS
Applicant
RADIOMETER MEDICAL APS
AAKANDEVEJ 21
BROENSHOEJ,  DK DK-2700
Applicant Contact SOEREN BOEGESTRAND
Correspondent
RADIOMETER MEDICAL APS
AAKANDEVEJ 21
BROENSHOEJ,  DK DK-2700
Correspondent Contact SOEREN BOEGESTRAND
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKR  
JFP   JGS   JIX   JJY   KHP   KQI  
MQM  
Date Received01/22/2016
Decision Date 11/04/2016
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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