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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 K963964
Device Name AVL COMPACT 3 PH/BLOOD GAS ANALYZER
Applicant
Avl Scientific Corp.
33 Mansell Court
Roswell,  GA  30076 -4807
Applicant Contact RANDY BYRD
Correspondent
Avl Scientific Corp.
33 Mansell Court
Roswell,  GA  30076 -4807
Correspondent Contact RANDY BYRD
Regulation Number862.1120
Classification Product Code
CHL  
Date Received10/02/1996
Decision Date 11/29/1996
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
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