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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 K991417
Device Name ABL 735 ANALYZER
Applicant
RADIOMETER AMERICA, INC.
810 SHARON DR.
WESTLAKE,  OH  44145 -1598
Applicant Contact VINCE SIGMUND
Correspondent
RADIOMETER AMERICA, INC.
810 SHARON DR.
WESTLAKE,  OH  44145 -1598
Correspondent Contact VINCE SIGMUND
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   CIG   JFP  
JGS   MQM  
Date Received04/23/1999
Decision Date 11/24/1999
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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