K-number	K240465
Device name	O-arm O2 Imaging System
Applicant	Medtronic Navigation, Inc.
Product code	OWB
Device class	Class II
Decision date	Jun 21, 2024
Decision	Substantially Equivalent
Regulation	892.1650

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View the full FDA submission: accessdata.fda.gov

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O-arm O2 Imaging System

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