FDA 510(k)

Echo

K-Number: K232236 · 2023-10-20

Decision Date2023-10-20

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Echo is a medical device manufactured by Quanta System Spa. It received FDA 510(k) clearance on 2023-10-20 under approval number K232236. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Echo?

Echo is a medical device that received FDA 510(k) clearance on 2023-10-20. It is manufactured by Quanta System Spa. The 510(k) number is K232236.

When was Echo approved by the FDA?

Echo received FDA 510(k) clearance on 2023-10-20, under approval number K232236.

What company makes Echo?

Echo is manufactured by Quanta System Spa.

What is the FDA product code for Echo?

The FDA product code for Echo is GEX. This falls under the Gastroenterology category.

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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.