K-number	K053648
Device name	PIONEER TC8080, COMPANION III
Applicant	Viasys Neuro Care
Product code	IYN
Device class	Class II
Decision date	Jan 24, 2006
Decision	Substantially Equivalent
Regulation	892.1550

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View the full FDA submission: accessdata.fda.gov

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PIONEER TC8080, COMPANION III

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