K-number	K083749
Device name	CARDIOVIEW32 REVIEW MODULE
Applicant	Qrs Diagnostic, LLC
Product code	LOS
Device class	Class unclassified
Decision date	Mar 10, 2009
Decision	Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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CARDIOVIEW32 REVIEW MODULE

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