Ziehm RFD 3D Tracker
K-Number: K180816 · 2018-07-11
ApplicantMedtronic Navigation
Decision Date2018-07-11
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Ziehm RFD 3D Tracker is a medical device manufactured by Medtronic Navigation. It received FDA 510(k) clearance on 2018-07-11 under approval number K180816. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ziehm RFD 3D Tracker?
Ziehm RFD 3D Tracker is a medical device that received FDA 510(k) clearance on 2018-07-11. It is manufactured by Medtronic Navigation. The 510(k) number is K180816.
When was Ziehm RFD 3D Tracker approved by the FDA?
Ziehm RFD 3D Tracker received FDA 510(k) clearance on 2018-07-11, under approval number K180816.
What company makes Ziehm RFD 3D Tracker?
Ziehm RFD 3D Tracker is manufactured by Medtronic Navigation.
What is the FDA product code for Ziehm RFD 3D Tracker?
The FDA product code for Ziehm RFD 3D Tracker is OLO.
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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.