Gastric Alimetry System

System, Electrogastrography (egg)

Alimetry Ltd.

The following data is part of a premarket notification filed by Alimetry Ltd. with the FDA for Gastric Alimetry System.

Pre-market Notification Details

Device IDK213924
510k NumberK213924
Device Name:Gastric Alimetry System
ClassificationSystem, Electrogastrography (egg)
Applicant Alimetry Ltd. 70 Symonds Street Grafton,  NZ 1010
ContactYaara Yarmut
CorrespondentJanice Hogan
Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia,  PA  19115
Product CodeMYE  
CFR Regulation Number876.1735 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-15
Decision Date2022-06-03

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