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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 K980130
Device Name ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
Applicant
RADIOMETER AMERICA, INC.
810 SHARON DR.
WESTLAKE,  OH  44145 -1598
Applicant Contact DONALD L BAKER
Correspondent
RADIOMETER AMERICA, INC.
810 SHARON DR.
WESTLAKE,  OH  44145 -1598
Correspondent Contact DONALD L BAKER
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   JFP   JGS  
KHP  
Date Received01/14/1998
Decision Date 02/09/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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