Clearance Summary
BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG received FDA 510(k) clearance under submission number K993708, sponsored by Biomagnetic 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 1999-12-03.
- Submission: K993708
- Applicant / Sponsor: Biomagnetic Technologies, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 1999-12-03
Classification & Regulation
This clearance is catalogued under FDA product code OLX and 21 CFR 882.1400, within the Neurology review panel as a Class II device.