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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Elucent Medical, Inc.. It received FDA 510(k) clearance on 2019-03-22 under 510(k) 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. The listed applicant is Elucent Medical, Inc.. The 510(k) number is K183400.

When did EnVisio Navigation Sytem receive FDA 510(k) clearance?

EnVisio Navigation Sytem received FDA 510(k) clearance on 2019-03-22, under 510(k) number K183400.

Who is the listed applicant for EnVisio Navigation Sytem?

The FDA 510(k) record lists Elucent Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EnVisio Navigation Sytem?

The FDA product code for EnVisio Navigation Sytem is NEU.

Other records listing Elucent Medical, Inc. as applicant

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Related Devices (Code: NEU)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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