FDA 510(k)

G-scan Brio, S-scan

K-Number: K161973 · 2016-10-25

Decision Date2016-10-25

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

G-scan Brio, S-scan is a medical device manufactured by Esaote, S.p.A.. It received FDA 510(k) clearance on 2016-10-25 under approval number K161973. 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, S-scan?

G-scan Brio, S-scan is a medical device that received FDA 510(k) clearance on 2016-10-25. It is manufactured by Esaote, S.p.A.. The 510(k) number is K161973.

When was G-scan Brio, S-scan approved by the FDA?

G-scan Brio, S-scan received FDA 510(k) clearance on 2016-10-25, under approval number K161973.

What company makes G-scan Brio, S-scan?

G-scan Brio, S-scan is manufactured by Esaote, S.p.A..

What is the FDA product code for G-scan Brio, S-scan?

The FDA product code for G-scan Brio, S-scan is LNH.

Other Devices by Esaote, S.p.A.

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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.