K-number	K183053
Device name	Olympus Small Intestinal Capsule Endoscope System
Applicant	Olympus Medical Systems Corp.
Product code	NEZ
Device class	Class II
Decision date	Mar 5, 2019
Decision	Substantially Equivalent
Regulation	876.1300

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Source

View the full FDA submission: accessdata.fda.gov

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Olympus Small Intestinal Capsule Endoscope System

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