Clearance Summary
DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH received FDA 510(k) clearance under submission number K051357, sponsored by Digitimer , 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 2005-09-20.
- Submission: K051357
- Applicant / Sponsor: Digitimer , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 2005-09-20
Classification & Regulation
This clearance is catalogued under FDA product code GWF and 21 CFR 882.1870, within the Neurology review panel as a Class II device.