Clearance Summary
R-40 EEG Amplifier received FDA 510(k) clearance under submission number K151600, sponsored by Lifelines , 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 2015-10-23.
- Submission: K151600
- Applicant / Sponsor: Lifelines , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1835
- Decision date: 2015-10-23
Classification & Regulation
This clearance is catalogued under FDA product code GWL and 21 CFR 882.1835, within the Neurology review panel as a Class II device.