K-number	K110120
Device name	ECHELON RAPID CARDIAC COIL
Applicant	Hitachi Medical Systems America, Inc.
Product code	MOS
Device class	Class II
Decision date	Feb 25, 2011
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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ECHELON RAPID CARDIAC COIL

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