Clearance Summary
HEMOBAND, MODELS HB-NS AND HB-NSXL received FDA 510(k) clearance under submission number K081740, sponsored by Innovations For Access, 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 2009-03-12.
- Submission: K081740
- Applicant / Sponsor: Innovations For Access, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2009-03-12
Classification & Regulation
This clearance is catalogued under FDA product code KOC and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.