Clearance Summary
SmartHDM-510 System received FDA 510(k) clearance under submission number K201765, sponsored by Mesa Laboratories, 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 2020-09-02.
- Submission: K201765
- Applicant / Sponsor: Mesa Laboratories, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2020-09-02
Classification & Regulation
This clearance is catalogued under FDA product code FIZ and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.