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FDA 510(k)

Gastric Alimetry System

K-Number: K213924 · 2022-06-03

ApplicantAlimetry , Ltd.
Decision Date2022-06-03
Product CodeMYE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Gastric Alimetry System is the device name listed in this FDA 510(k) record. The listed applicant is Alimetry , Ltd.. It received FDA 510(k) clearance on 2022-06-03 under 510(k) 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. The listed applicant is Alimetry , Ltd.. The 510(k) number is K213924.

When did Gastric Alimetry System receive FDA 510(k) clearance?

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

Who is the listed applicant for Gastric Alimetry System?

The FDA 510(k) record lists Alimetry , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gastric Alimetry System?

The FDA product code for Gastric Alimetry System is MYE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05812339Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and ControlsENROLLING_BY_INVITATIONNCT07632378The Effect of taVNS and Upper GI MotilityRECRUITINGNCT06401746Body Surface Gastric Mapping in Patients on SemaglutideCOMPLETEDNCT06411574Body Surface Gastric Mapping vs Gastric Emptying Scintigraphy on Clinical Management in GastroparesisCOMPLETEDNCT06854120Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment EffectsRECRUITING

Other records listing Alimetry , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252504Gastric AlimetryK240946Gastric AlimetryK232925Gastric Alimetry SystemK223398Gastric Alimetry System

Related Devices (Code: MYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252504Gastric AlimetryAlimetry , Ltd.K240946Gastric AlimetryAlimetry , Ltd.K232925Gastric Alimetry SystemAlimetry , Ltd.K223398Gastric Alimetry SystemAlimetry , Ltd.K212954G-Tech Wireless Patch System (WPS)G-Tech Medical

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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