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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 K002290
Device Name ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS)
Applicant
RADIOMETER MEDICAL A/S
AKANDEVEJ 21
BRONSHOJ,  DK DK-2700
Applicant Contact KIRSTEN RONO
Correspondent
RADIOMETER MEDICAL A/S
AKANDEVEJ 21
BRONSHOJ,  DK DK-2700
Correspondent Contact KIRSTEN RONO
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   CIG   GKF  
JFP   JGS   KHP  
Date Received07/27/2000
Decision Date 09/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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