Clearance Summary
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) received FDA 510(k) clearance under submission number K211372, sponsored by Mahana Therapeutics, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-06-02.
- Submission: K211372
- Applicant / Sponsor: Mahana Therapeutics, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5960
- Decision date: 2021-06-02
Classification & Regulation
This clearance is catalogued under FDA product code QMY and 21 CFR 876.5960, within the Gastroenterology, Urology review panel as a Class II device.