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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
510(k) Number K951485
Device Name AVOXIMETER 4000
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 Number862.3220
Classification Product Code
JKS  
Date Received03/30/1995
Decision Date 11/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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