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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 K100777
Device Name ABL837 FLEX ANALYZER
Applicant
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Applicant Contact ROWENA JANSSON
Correspondent
Radiometer Medical Aps
Akandevej 21 Dk-2700
Bronshoj,  DK
Correspondent Contact ROWENA JANSSON
Regulation Number862.1120
Classification Product Code
CHL  
Date Received03/18/2010
Decision Date 12/10/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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