Clearance Summary
MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 received FDA 510(k) clearance under submission number K030332, sponsored by Bionicare Medical Technologies, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2003-06-06.
- Submission: K030332
- Applicant / Sponsor: Bionicare Medical Technologies, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2003-06-06
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.