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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
OR-NIM MEDICAL LTD.
1 yodfat st
lod,  IL 71291
Original Contact michal balberg
Regulation Number870.2700
Classification Product Code
MUD  
Subsequent Product Code
DPW  
Date Received03/30/2010
Decision Date 01/25/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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