K-number	K141497
Device name	PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)
Applicant	Osstem Implant Co., Ltd.
Product code	EHD
Device class	Class II
Decision date	Aug 26, 2014
Decision	Substantially Equivalent
Regulation	872.1800

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View the full FDA submission: accessdata.fda.gov

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PORTABLE X-RAY SYSTEM (MODEL:EXARO,XRAY2GO)

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