Home / 510(k) Clearances / K163687

510(k) K163687

OLINDA EXM by Hermes Medical Solutions AB — Product Code IYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2017
Date Received
December 28, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Scintillation (Gamma)
Device Class
Class I
Regulation Number
892.1100
Review Panel
RA
Submission Type

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