K-number	K131601
Device name	DELL U3014 WITH QUBYX PERFECTLUM BUNDLE
Applicant	Qubyx Limited
Product code	PGY
Device class	Class II
Decision date	Jul 7, 2014
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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DELL U3014 WITH QUBYX PERFECTLUM BUNDLE

Everything you need for a 510(k) submission. Nothing you don't.