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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 K990092
Device Name AVL OMNI MODULAR ANALYZER
Applicant
Avl Scientific Corp.
33 Mansell Ct.
Roswell,  GA  30076
Applicant Contact RANDY BYRD
Correspondent
Avl Scientific Corp.
33 Mansell Ct.
Roswell,  GA  30076
Correspondent Contact RANDY BYRD
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CDS   CEM   CGA   CGZ   GKF  
GKR   GLY   JFP   JGS   KHP  
Date Received01/11/1999
Decision Date 01/29/1999
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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