O-arm O2 Imaging System
K-Number: K240465 · 2024-06-21
ApplicantMedtronic Navigation, Inc.
Decision Date2024-06-21
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
O-arm O2 Imaging System is a medical device manufactured by Medtronic Navigation, Inc.. It received FDA 510(k) clearance on 2024-06-21 under approval number K240465. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the O-arm O2 Imaging System?
O-arm O2 Imaging System is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Medtronic Navigation, Inc.. The 510(k) number is K240465.
When was O-arm O2 Imaging System approved by the FDA?
O-arm O2 Imaging System received FDA 510(k) clearance on 2024-06-21, under approval number K240465.
What company makes O-arm O2 Imaging System?
O-arm O2 Imaging System is manufactured by Medtronic Navigation, Inc..
What is the FDA product code for O-arm O2 Imaging System?
The FDA product code for O-arm O2 Imaging System is OWB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.