Clearance Summary
PATHWAY - ATS/CHEPS received FDA 510(k) clearance under submission number K052357, sponsored by Medoc Ltd. Advanced Medical Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2006-01-19.
- Submission: K052357
- Applicant / Sponsor: Medoc Ltd. Advanced Medical Systems
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1870
- Decision date: 2006-01-19
Classification & Regulation
This clearance is catalogued under FDA product code NTU and 21 CFR 882.1870, within the Neurology review panel as a Class II device.