K-number	K172811
Device name	EsophyX Z, EsophyX2 HD
Applicant	Endogastric Solutions, Inc.
Product code	ODE
Device class	Class II
Decision date	Oct 19, 2017
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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EsophyX Z, EsophyX2 HD

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