OARtrac System
K-Number: K182395 · 2019-03-22
ApplicantRadialdyne, LLC
Decision Date2019-03-22
Product CodeNZT
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
OARtrac System is a medical device manufactured by Radialdyne, LLC. It received FDA 510(k) clearance on 2019-03-22 under approval number K182395. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OARtrac System?
OARtrac System is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Radialdyne, LLC. The 510(k) number is K182395.
When was OARtrac System approved by the FDA?
OARtrac System received FDA 510(k) clearance on 2019-03-22, under approval number K182395.
What company makes OARtrac System?
OARtrac System is manufactured by Radialdyne, LLC.
What is the FDA product code for OARtrac System?
The FDA product code for OARtrac System is NZT.
Related Devices (Code: NZT)
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.