Clearance Summary
ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 received FDA 510(k) clearance under submission number K082056, sponsored by Life-Tech, Inc.. 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 2008-11-07.
- Submission: K082056
- Applicant / Sponsor: Life-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1725
- Decision date: 2008-11-07
Classification & Regulation
This clearance is catalogued under FDA product code FFX and 21 CFR 876.1725, within the Gastroenterology, Urology review panel as a Class II device.