Mobility+ Enteral Feeding System

Gastrointestinal Tubes With Enteral Specific Connectors

Rockfield Medical

The following data is part of a premarket notification filed by Rockfield Medical with the FDA for Mobility+ Enteral Feeding System.

Pre-market Notification Details

Device IDK222678
510k NumberK222678
Device Name:Mobility+ Enteral Feeding System
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant Rockfield Medical iHub GMIT, Dublin Road Galway,  IE H91 DCH9
ContactOrla Connaughton
CorrespondentOrla Connaughton
Rockfield Medical iHub GMIT, Dublin Road Galway,  IE H91 DCH9
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-06
Decision Date2022-10-27

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