K-number	K211305
Device name	ANNE One
Applicant	Sibel, Inc.
Product code	DRG
Device class	Class II
Decision date	Sep 14, 2021
Decision	Substantially Equivalent
Regulation	870.2910

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Source

View the full FDA submission: accessdata.fda.gov

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ANNE One

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