Clearance Summary
NEUROLINK IP MODEL: PK1117 received FDA 510(k) clearance under submission number K100683, sponsored by Natus Medical Incorporated. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2010-04-09.
- Submission: K100683
- Applicant / Sponsor: Natus Medical Incorporated
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2010-04-09
Classification & Regulation
This clearance is catalogued under FDA product code GWQ and 21 CFR 882.1400, within the Neurology review panel as a Class II device.