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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter, tissue saturation
510(k) Number K100875
Device Name CEROX, MODEL 321OF
Original Applicant
1 yodfat st
lod,  IS 71291
Original Contact michal balberg
Regulation Number870.2700
Classification Product Code
Subsequent Product Code
Date Received03/30/2010
Decision Date 01/25/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No