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510(k) K162117

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2016
Date Received
July 29, 2016
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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