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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 K143219
Device Name NIRO-200NX
Applicant
Hamamatsu Photonics K.K.
812 Joko-Cho
Highashi-Ku
Hamamatsu City,  JP 431-3196
Applicant Contact SUSUMU SUZUKI
Correspondent
Hyman, Phelps & McNamara, P.C.
700 Thirteenth St. N.W
Suite 1200
Washington,  DC  20005
Correspondent Contact JEFFREY K. SHAPIRO
Regulation Number870.2700
Classification Product Code
MUD  
Subsequent Product Code
DQA  
Date Received11/10/2014
Decision Date 07/31/2015
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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