FDA 510(k) Application Details - K222678

Device Classification Name	More FDA Info for this Device
510(K) Number	K222678
Device Name	Mobility+ Enteral Feeding System
Applicant	Rockfield Medical iHub GMIT, Dublin Road Galway H91 DCH9 IE Other 510(k) Applications for this Company
Contact	Orla Connaughton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/06/2022
Decision Date	10/27/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review