K-number	K122410
Device name	I RUNE (I-200L)
Applicant	Medirune Co, Ltd.
Product code	NUH
Device class	Class II
Decision date	Nov 12, 2013
Decision	Substantially Equivalent
Regulation	882.5890

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View the full FDA submission: accessdata.fda.gov

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I RUNE (I-200L)

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