Clearance Summary
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables received FDA 510(k) clearance under submission number K152670, sponsored by Medos International SARL. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2016-01-22.
- Submission: K152670
- Applicant / Sponsor: Medos International SARL
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1620
- Decision date: 2016-01-22
Classification & Regulation
This clearance is catalogued under FDA product code GWM and 21 CFR 882.1620, within the Neurology review panel as a Class II device.