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FDA 510(k)

Medtronic O-arm O2 Imaging System

K-Number: K173664 · 2017-12-29

ApplicantMedtronic, Inc.
Decision Date2017-12-29
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Medtronic O-arm O2 Imaging System is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2017-12-29 under approval number K173664. 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 Medtronic O-arm O2 Imaging System?

Medtronic O-arm O2 Imaging System is a medical device that received FDA 510(k) clearance on 2017-12-29. It is manufactured by Medtronic, Inc.. The 510(k) number is K173664.

When was Medtronic O-arm O2 Imaging System approved by the FDA?

Medtronic O-arm O2 Imaging System received FDA 510(k) clearance on 2017-12-29, under approval number K173664.

What company makes Medtronic O-arm O2 Imaging System?

Medtronic O-arm O2 Imaging System is manufactured by Medtronic, Inc..

What is the FDA product code for Medtronic O-arm O2 Imaging System?

The FDA product code for Medtronic 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.

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