K-number	K182004
Device name	PENTAX Medical Endoscopic Ultrasound System
Applicant	Pentax of America, Inc.
Product code	ODG
Device class	Class II
Decision date	Aug 21, 2018
Decision	Substantially Equivalent
Regulation	876.1500

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Source

View the full FDA submission: accessdata.fda.gov

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PENTAX Medical Endoscopic Ultrasound System

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