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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
Recalls CDRH Recalls
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