Clearance Summary
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX received FDA 510(k) clearance under submission number K990660, sponsored by Nmt Neurosciences Implants S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-09-23.
- Submission: K990660
- Applicant / Sponsor: Nmt Neurosciences Implants S.A.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5550
- Decision date: 1999-09-23
Classification & Regulation
This clearance is catalogued under FDA product code JXG and 21 CFR 882.5550, within the Neurology review panel as a Class II device.