K-number	K092479
Device name	SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
Applicant	Dyn'R
Product code	IYE
Device class	Class II
Decision date	Jan 11, 2010
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL

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