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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 K964821
Device Name COVEROX SHEATH MODELS NUMBER PS65, PS67, EPS65 AND EPS67
Original Applicant
VENTREX, INC.
3007 bunsen ave., unit l & k
ventura,  CA  93003
Original Contact robert b guthrie
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/02/1996
Decision Date 07/16/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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