K-number	K192364
Device name	GXR-Series Diagnostic X-Ray System
Applicant	DRGEM Corporation
Product code	KPR
Device class	Class II
Decision date	Sep 26, 2019
Decision	Substantially Equivalent
Regulation	892.1680

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View the full FDA submission: accessdata.fda.gov

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GXR-Series Diagnostic X-Ray System

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