510(k) K051645

EVIS EXERA 160A SYSTEM by Olympus Medical Systems Corporation — Product Code NWB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 13, 2005
Date Received: June 20, 2005
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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