510(k) K053547
K053547 is an FDA 510(k) premarket notification submitted by The Smartpill Corporation for the device "SMARTPILL GI MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 2006. The device falls under product code NYV (Gastrointestinal Motility System, Capsule), a Class II device regulated under 21 CFR 876.1725. The Smartpill Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2006
- Date Received
- December 20, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointestinal Motility System, Capsule
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.