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FDA 510(k)

Vesalius

K-Number: K152933 · 2016-03-23

ApplicantTelea Electronic Engineering Srl
Decision Date2016-03-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vesalius is the device name listed in this FDA 510(k) record. The listed applicant is Telea Electronic Engineering Srl. It received FDA 510(k) clearance on 2016-03-23 under 510(k) number K152933. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vesalius?

Vesalius is a medical device that received FDA 510(k) clearance on 2016-03-23. The listed applicant is Telea Electronic Engineering Srl. The 510(k) number is K152933.

When did Vesalius receive FDA 510(k) clearance?

Vesalius received FDA 510(k) clearance on 2016-03-23, under 510(k) number K152933.

Who is the listed applicant for Vesalius?

The FDA 510(k) record lists Telea Electronic Engineering Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vesalius?

The FDA product code for Vesalius is GEI.

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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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