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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
Applicant
Or-Nim Medical , Ltd.
1 Yodfat St.
Lod,  IL 71291
Applicant Contact MICHAL BALBERG
Correspondent
Or-Nim Medical , Ltd.
1 Yodfat St.
Lod,  IL 71291
Correspondent 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 Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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