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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 K932642
Device Name AVL 9110PH 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 Received06/02/1993
Decision Date 10/14/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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