Clearance Summary
BIO-LOGIC SLEEPSCAN NETLINK received FDA 510(k) clearance under submission number K003681, sponsored by Bio-Logic Systems Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2000-12-21.
- Submission: K003681
- Applicant / Sponsor: Bio-Logic Systems Corp.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2000-12-21
Classification & Regulation
This clearance is catalogued under FDA product code OLV and 21 CFR 882.1400, within the Neurology review panel as a Class II device.