K-number	K110414
Device name	QLAB 8.1 QUANTIFICATION SOFTWARE
Applicant	Philips Ultrasound, Inc.
Product code	LLZ
Device class	Class II
Decision date	Jun 21, 2011
Decision	Substantially Equivalent
Regulation	892.2050

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Source

View the full FDA submission: accessdata.fda.gov

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QLAB 8.1 QUANTIFICATION SOFTWARE

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