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FDA 510(k)

G-SCAN BRIO

K-Number: K133490 · 2013-12-30

ApplicantEsaote, S.p.A.
Decision Date2013-12-30
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

G-SCAN BRIO is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2013-12-30 under 510(k) number K133490. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-SCAN BRIO?

G-SCAN BRIO is a medical device that received FDA 510(k) clearance on 2013-12-30. The listed applicant is Esaote, S.p.A.. The 510(k) number is K133490.

When did G-SCAN BRIO receive FDA 510(k) clearance?

G-SCAN BRIO received FDA 510(k) clearance on 2013-12-30, under 510(k) number K133490.

Who is the listed applicant for G-SCAN BRIO?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G-SCAN BRIO?

The FDA product code for G-SCAN BRIO is LNH.

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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.

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