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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 K061974
Device Name GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT
Applicant
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Applicant Contact CAROL MARBLE
Correspondent
INSTRUMENTATION LABORATORY CO.
180 HARTWELL ROAD
BEDFORD,  MA  01730
Correspondent Contact CAROL MARBLE
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   CGZ   GHS   GKF  
GKR   GLK   JFP   JGS   JJY   KHP  
Date Received07/12/2006
Decision Date 09/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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