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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 K110416
Device Name ABL835 FLEX ANALYZER WITH PLEURAL PH
Applicant
RADIOMETER MEDICAL APS
AAKANDEVEJ 21
BROENSHOEJY,  DK DK-2700
Applicant Contact SOREN BOGESTRAND
Correspondent
RADIOMETER MEDICAL APS
AAKANDEVEJ 21
BROENSHOEJY,  DK DK-2700
Correspondent Contact SOREN BOGESTRAND
Regulation Number862.1120
Classification Product Code
CHL  
Date Received02/14/2011
Decision Date 03/24/2011
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
Recalls CDRH Recalls
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