Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name gastrointestinal tubes with enteral specific connectors
510(k) Number K222678
Device Name Mobility+ Enteral Feeding System
Applicant
Rockfield Medical
iHub GMIT, Dublin Road
Galway,  IE H91 DCH9
Applicant Contact Orla Connaughton
Correspondent
Rockfield Medical
iHub GMIT, Dublin Road
Galway,  IE H91 DCH9
Correspondent Contact Orla Connaughton
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
KNT  
Date Received09/06/2022
Decision Date 10/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-