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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K922075
Device Name AVOXIMETER
Applicant
A-Vox Systems, Inc.
15315 Grey Fox Terrace
San Antonio,  TX  78255
Applicant Contact A. P SHEPHERD
Correspondent
A-Vox Systems, Inc.
15315 Grey Fox Terrace
San Antonio,  TX  78255
Correspondent Contact A. P SHEPHERD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/04/1992
Decision Date 11/04/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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