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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 K895181
Device Name ABL500 BLOOD GAS SYSTEM
Applicant
RADIOMETER AMERICA, INC.
811 SHARON DR.
WESTLAKE,  OH  44145 -1598
Applicant Contact DONALD L BAKER
Correspondent
RADIOMETER AMERICA, INC.
811 SHARON DR.
WESTLAKE,  OH  44145 -1598
Correspondent Contact DONALD L BAKER
Regulation Number862.1120
Classification Product Code
CHL  
Date Received08/11/1989
Decision Date 10/06/1989
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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