EnVisio Navigation Sytem
K-Number: K183400 · 2019-03-22
ApplicantElucent Medical, Inc.
Decision Date2019-03-22
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
EnVisio Navigation Sytem is a medical device manufactured by Elucent Medical, Inc.. It received FDA 510(k) clearance on 2019-03-22 under approval number K183400. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EnVisio Navigation Sytem?
EnVisio Navigation Sytem is a medical device that received FDA 510(k) clearance on 2019-03-22. It is manufactured by Elucent Medical, Inc.. The 510(k) number is K183400.
When was EnVisio Navigation Sytem approved by the FDA?
EnVisio Navigation Sytem received FDA 510(k) clearance on 2019-03-22, under approval number K183400.
What company makes EnVisio Navigation Sytem?
EnVisio Navigation Sytem is manufactured by Elucent Medical, Inc..
What is the FDA product code for EnVisio Navigation Sytem?
The FDA product code for EnVisio Navigation Sytem is NEU.
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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.