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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 K963415
Device Name VENTREX OXYGEN SENSOR
Applicant
Ventrex, LLC
159 Gibraltar Rd.
Horsham,  PA  19044
Applicant Contact MARY HUEGEL
Correspondent
Ventrex, LLC
159 Gibraltar Rd.
Horsham,  PA  19044
Correspondent Contact MARY HUEGEL
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/30/1996
Decision Date 11/25/1996
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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