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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 K111897
Device Name ABL90
Applicant
RADIOMETER MEDICAL APS
AAKANDEVEJ 21
COPENHAGEN,  DK 2100
Applicant Contact Martin Gabler
Correspondent
RADIOMETER MEDICAL APS
AAKANDEVEJ 21
COPENHAGEN,  DK 2100
Correspondent Contact Martin Gabler
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKR  
JFP   JGS   JIX   JJY   KHP   KQI  
Date Received07/05/2011
Decision Date 07/19/2011
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
Recalls CDRH Recalls
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