FDA 510(k)

O-arm O2 Imaging System

K-Number: K200074 · 2020-04-24

Decision Date2020-04-24

Product CodeOWB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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 2020-04-24 under 510(k) number K200074. 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 2020-04-24. The listed applicant is Medtronic, Inc.. The 510(k) number is K200074.

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

O-arm O2 Imaging System received FDA 510(k) clearance on 2020-04-24, under 510(k) number K200074.

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

The FDA product code for 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.