FDA 510(k)

Medtronic O-arm O2 Imaging System

K-Number: K173664 · 2017-12-29

Decision Date2017-12-29

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Medtronic O-arm O2 Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2017-12-29 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K173664.

When did Medtronic O-arm O2 Imaging System receive FDA 510(k) clearance?

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

Who is the listed applicant for Medtronic O-arm O2 Imaging System?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.