Medtronic O-arm O2 Imaging System
FDA 510(k) K173664 · Medtronic, Inc.
510(k) numberK173664
Submission
- Device name
- Medtronic O-arm O2 Imaging System
- Applicant
- Medtronic, Inc.
Littleton, MA, US - Received
- November 29, 2017
- Decision date
- December 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Medtronic O-arm O2 Imaging System cleared by the FDA?
Medtronic O-arm O2 Imaging System (K173664) received a 510(k) decision of Substantially Equivalent on December 29, 2017, 30 days after the submission was received.
What is the product code of K173664?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.