The following data is part of a premarket notification filed by Rockfield Medical with the FDA for Mobility+ Enteral Feeding System.
| Device ID | K222678 |
| 510k Number | K222678 |
| Device Name: | Mobility+ Enteral Feeding System |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Rockfield Medical iHub GMIT, Dublin Road Galway, IE H91 DCH9 |
| Contact | Orla Connaughton |
| Correspondent | Orla Connaughton Rockfield Medical iHub GMIT, Dublin Road Galway, IE H91 DCH9 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-06 |
| Decision Date | 2022-10-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391537090035 | K222678 | 000 |
| 05391537090028 | K222678 | 000 |
| 05391537090011 | K222678 | 000 |
| 05391537090004 | K222678 | 000 |