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510(k) K173921

HD-500 Video Endoscope System by Sonoscape Medical Corp. — Product Code NWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2018
Date Received
December 26, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Accessories, Narrow Band Spectrum
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.

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