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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 K944089
Device Name AVL OPTI PH/BLOOD GAS ANALYZER
Applicant
Avl Scientific Corp.
33 Mansell Ct.
P.O. Box 337
Roswell,  GA  30077
Applicant Contact RANDY BYRD
Correspondent
Avl Scientific Corp.
33 Mansell Ct.
P.O. Box 337
Roswell,  GA  30077
Correspondent Contact RANDY BYRD
Regulation Number862.1120
Classification Product Code
CHL  
Date Received08/22/1994
Decision Date 10/20/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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