510(k) K092342
K092342 is an FDA 510(k) premarket notification submitted by The Smartpill Corporation for the device "SMARTPILL GI MONITORING SYSTEM, VERSION 2.0". The FDA issued a decision of Substantially Equivalent on October 30, 2009. 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
- October 30, 2009
- Date Received
- August 4, 2009
- 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.