K-number	K171396
Device name	ODFS Pace XL
Applicant	Odstock Medical, Ltd.
Product code	GZI
Device class	Class II
Decision date	Jan 31, 2018
Decision	Substantially Equivalent
Regulation	882.5810

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Source

View the full FDA submission: accessdata.fda.gov

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ODFS Pace XL

Everything you need for a 510(k) submission. Nothing you don't.