Clearance Summary
DOLPHIN NEUROSTIM OTC received FDA 510(k) clearance under submission number K133789, sponsored by Acumed Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2015-03-04.
- Submission: K133789
- Applicant / Sponsor: Acumed Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2015-03-04
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.