510(k) K052338
K052338 is an FDA 510(k) premarket notification submitted by Medical Measurement Systems B.V. for the device "SOLAR GI". The FDA issued a decision of Substantially Equivalent on Dec 15, 2005. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Medical Measurement Systems B.V. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 15, 2005
- Date Received
- Aug 26, 2005
- Clearance Type
- Special
- 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)