510(k) K160287
K160287 is an FDA 510(k) premarket notification submitted by Mui Scientific for the device "Rapid Barostat Bag (RBB) Pump and Catheter". The FDA issued a decision of Substantially Equivalent on March 14, 2017. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Mui Scientific has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2017
- Date Received
- February 3, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Gastrointestinal Motility (Electrical)
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type