Clearance Summary
H2O received FDA 510(k) clearance under submission number K974587, sponsored by Grass-Telefactor Product Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1998-03-09.
- Submission: K974587
- Applicant / Sponsor: Grass-Telefactor Product Group
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1998-03-09
Classification & Regulation
This clearance is catalogued under FDA product code OLV and 21 CFR 882.1400, within the Neurology review panel as a Class II device.