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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
510(k) Number K896311
Device Name OPTEX BLOOD GAS MONITORING SYSTEM
Applicant
Optex Biomedical
2202 Timberloch Pl.,
Suite 135
The Woodlands,  TX  77380
Applicant Contact JEFF KASOFF
Correspondent
Optex Biomedical
2202 Timberloch Pl.,
Suite 135
The Woodlands,  TX  77380
Correspondent Contact JEFF KASOFF
Regulation Number868.1200
Classification Product Code
CCE  
Date Received11/01/1989
Decision Date 01/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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