510(k) K222678
K222678 is an FDA 510(k) premarket notification submitted by Rockfield Medical for the device "Mobility+ Enteral Feeding System". The FDA issued a decision of Substantially Equivalent on October 27, 2022. The device falls under product code PIF (Gastrointestinal Tubes With Enteral Specific Connectors), a Class II device regulated under 21 CFR 876.5980. Rockfield Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2022
- Date Received
- September 6, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
To facilitate enteral specific connections.