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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K932954
Device Name AVOXIMETER
Applicant
A-Vox Systems, Inc.
15315 Grey Fox Ter.
San Antonio,  TX  78255
Applicant Contact SHEPHERD
Correspondent
A-Vox Systems, Inc.
15315 Grey Fox Ter.
San Antonio,  TX  78255
Correspondent Contact SHEPHERD
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
GKR  
Date Received06/17/1993
Decision Date 12/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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