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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 K992859
Device Name ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
Applicant
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145 -1598
Applicant Contact VINCENT M SIGMUND
Correspondent
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145 -1598
Correspondent Contact VINCENT M SIGMUND
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GKF   JFP  
JGS   JJS   KHP  
Date Received08/25/1999
Decision Date 01/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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