510(k) K120997
K120997 is an FDA 510(k) premarket notification submitted by Crospon, Ltd. for the device "BAROSTAT SOFTWARE OPTION". The FDA issued a decision of Substantially Equivalent on August 27, 2012. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Crospon, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2012
- Date Received
- April 2, 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