510(k) K942247
K942247 is an FDA 510(k) premarket notification submitted by Sandhill Scientific, Inc. for the device "SMALL BOWEL ANALYSIS SOFTWARE". The FDA issued a decision of Substantially Equivalent on April 9, 1996. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Sandhill Scientific, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1996
- Date Received
- May 9, 1994
- 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