K-number	K112768
Device name	CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING
Applicant	Calypso Medical Technologies, Inc.
Product code	LHN
Device class	Class II
Decision date	Nov 18, 2011
Decision	Substantially Equivalent
Regulation	892.5050

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View the full FDA submission: accessdata.fda.gov

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CALYPSO SYSTEMS WITH DYNAMIC EDGE GATING

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