Clearance Summary
OSTOM-I ALERT received FDA 510(k) clearance under submission number K140938, sponsored by 11 Health and Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2014-10-10.
- Submission: K140938
- Applicant / Sponsor: 11 Health and Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 2014-10-10
Classification & Regulation
This clearance is catalogued under FDA product code EXB and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.