510(k) K120524
K120524 is an FDA 510(k) premarket notification submitted by Mui Scientific for the device "SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 21, 2012. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Mui Scientific has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 21, 2012
- Date Received
- Feb 22, 2012
- 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
- 510(k)