K-number	K120922
Device name	GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT
Applicant	Selectivemed Components, Inc.
Product code	IPF
Device class	Class II
Decision date	Feb 7, 2013
Decision	Substantially Equivalent
Regulation	890.5850

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View the full FDA submission: accessdata.fda.gov

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GUARDIAN DYSPHAGIA DUAL CHANNEL NMES UNIT

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