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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 K954612
Device Name ABL SYSTEM 625, 615, 605
Applicant
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145
Applicant Contact DONALD L BAKER
Correspondent
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact DONALD L BAKER
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Code
CGA  
Date Received10/05/1995
Decision Date 11/09/1995
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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