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FDA 510(k)

Gastric Alimetry System

K-Number: K213924 · 2022-06-03

Decision Date2022-06-03
Product CodeMYE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gastric Alimetry System is a medical device manufactured by Alimetry , Ltd.. It received FDA 510(k) clearance on 2022-06-03 under approval number K213924. The device is classified under product code MYE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gastric Alimetry System?

Gastric Alimetry System is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Alimetry , Ltd.. The 510(k) number is K213924.

When was Gastric Alimetry System approved by the FDA?

Gastric Alimetry System received FDA 510(k) clearance on 2022-06-03, under approval number K213924.

What company makes Gastric Alimetry System?

Gastric Alimetry System is manufactured by Alimetry , Ltd..

What is the FDA product code for Gastric Alimetry System?

The FDA product code for Gastric Alimetry System is MYE.

Related Clinical Trials

Other Devices by Alimetry , Ltd.

Related Devices (Code: MYE)

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.