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510(k) K143219

NIRO-200NX by Hamamatsu Photonics K.K. — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2015
Date Received
November 10, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Tissue Saturation
Device Class
Class II
Regulation Number
870.2700
Review Panel
SU
Submission Type

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