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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
Recalls CDRH Recalls
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