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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, Gaseous-Phase
510(k) Number K971084
Device Name MODEL 02 OXYGEN ANALYZER
Applicant
Oxigraf, Inc.
1170 Terra Bella Ave.
Mountain View,  CA  94043
Applicant Contact BRUCE MCCAUL
Correspondent
Oxigraf, Inc.
1170 Terra Bella Ave.
Mountain View,  CA  94043
Correspondent Contact BRUCE MCCAUL
Regulation Number868.1720
Classification Product Code
CCL  
Date Received03/25/1997
Decision Date 07/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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