Clearance Summary
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS) received FDA 510(k) clearance under submission number K010548, sponsored by Radionics, A Division of Tyco Healthcare Group LP. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2001-03-12.
- Submission: K010548
- Applicant / Sponsor: Radionics, A Division of Tyco Healthcare Group LP
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2001-03-12
Classification & Regulation
This clearance is catalogued under FDA product code HAW and 21 CFR 882.4560, within the Neurology review panel as a Class II device.