K-number	K223140
Device name	AEON-C Stand Alone System
Applicant	Dio Medical, Inc.
Product code	OVE
Device class	Class II
Decision date	Dec 20, 2022
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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AEON-C Stand Alone System

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AEON-C Stand Alone System