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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 K153426
Device Name Ox-Imager CS
Applicant
Modulated Imaging, Inc.
17151 Gillette Ave.
Irvine,  CA  92604
Applicant Contact DAVID CUCCIA
Correspondent
O'Connell Regulatory Consultants, Inc.
5 Timber Ln.
North Reading,  MA  01864
Correspondent Contact MAUREEN O'CONNELL
Regulation Number870.2700
Classification Product Code
MUD  
Date Received11/25/2015
Decision Date 12/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT01484730
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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