PreXion3D Explorer EX
K-Number: K193329 · 2020-04-09
ApplicantPrexion Corporation
Decision Date2020-04-09
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PreXion3D Explorer EX is a medical device manufactured by Prexion Corporation. It received FDA 510(k) clearance on 2020-04-09 under approval number K193329. 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 EX?
PreXion3D Explorer EX is a medical device that received FDA 510(k) clearance on 2020-04-09. It is manufactured by Prexion Corporation. The 510(k) number is K193329.
When was PreXion3D Explorer EX approved by the FDA?
PreXion3D Explorer EX received FDA 510(k) clearance on 2020-04-09, under approval number K193329.
What company makes PreXion3D Explorer EX?
PreXion3D Explorer EX is manufactured by Prexion Corporation.
What is the FDA product code for PreXion3D Explorer EX?
The FDA product code for PreXion3D Explorer EX 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.