PreXion3D Explorer
K-Number: K190320 · 2019-04-15
ApplicantPrexion Corporation
Decision Date2019-04-15
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PreXion3D Explorer is a medical device manufactured by Prexion Corporation. It received FDA 510(k) clearance on 2019-04-15 under approval number K190320. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PreXion3D Explorer?
PreXion3D Explorer is a medical device that received FDA 510(k) clearance on 2019-04-15. It is manufactured by Prexion Corporation. The 510(k) number is K190320.
When was PreXion3D Explorer approved by the FDA?
PreXion3D Explorer received FDA 510(k) clearance on 2019-04-15, under approval number K190320.
What company makes PreXion3D Explorer?
PreXion3D Explorer is manufactured by Prexion Corporation.
What is the FDA product code for PreXion3D Explorer?
The FDA product code for PreXion3D Explorer is OAS.
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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.