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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 K043218
Device Name ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
Applicant
RADIOMETER MEDICAL APS
AKANDEVEJ 21
BRONSHOJ,  DK DK-2700
Applicant Contact LENE MEINECHE MARNAES
Correspondent
RADIOMETER MEDICAL APS
AKANDEVEJ 21
BRONSHOJ,  DK DK-2700
Correspondent Contact LENE MEINECHE MARNAES
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   CIG   GHS  
GKR   JFP   JGS   KHP   KQI   MQM  
Date Received11/22/2004
Decision Date 05/10/2005
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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