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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 K240998
Device Name ABL90 FLEX PLUS System
Applicant
Radiometer Medicals Aps
Åkandevej
Brønshøj,  DK 2700
Applicant Contact Andrea Swingle
Correspondent
Radiometer Medicals Aps
Åkandevej
Brønshøj,  DK 2700
Correspondent Contact Andrea Swingle
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
GHS   GKR  
Date Received04/11/2024
Decision Date 12/13/2024
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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