Clearance Summary
EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-SP-RP (PROPOSED) received FDA 510(k) clearance under submission number K010085, sponsored by Excel Tech. , 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 2001-03-15.
- Submission: K010085
- Applicant / Sponsor: Excel Tech. , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2001-03-15
Classification & Regulation
This clearance is catalogued under FDA product code OMB and 21 CFR 882.1400, within the Neurology review panel as a Class II device.