Clearance Summary
NET-2000 MICROCURRENT STIMULATOR received FDA 510(k) clearance under submission number K060158, sponsored by Auri-Stem Medical, 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 2006-10-13.
- Submission: K060158
- Applicant / Sponsor: Auri-Stem Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5800
- Decision date: 2006-10-13
Classification & Regulation
This clearance is catalogued under FDA product code QJQ and 21 CFR 882.5800, within the Neurology review panel as a Class II device.