K-number	K102373
Device name	CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
Applicant	Calypso Medical Technologies, Inc.
Product code	LHN
Device class	Class II
Decision date	Sep 30, 2010
Decision	Substantially Equivalent
Regulation	892.5050

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View the full FDA submission: accessdata.fda.gov

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CALYPSO SYSTEM WITH DYNAMIC EDGE GATING

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