Clearance Summary
BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 received FDA 510(k) clearance under submission number K052625, sponsored by Bionicare Medical Technologies, 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 2005-12-05.
- Submission: K052625
- Applicant / Sponsor: Bionicare Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2005-12-05
Classification & Regulation
This clearance is catalogued under FDA product code NYN and 21 CFR 882.5890, within the Neurology review panel as a Class II device.