Clearance Summary
HI-DOW-XP received FDA 510(k) clearance under submission number K102598, sponsored by Hi-Dow International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2011-05-13.
- Submission: K102598
- Applicant / Sponsor: Hi-Dow International, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2011-05-13
Classification & Regulation
This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.