Clearance Summary
OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII received FDA 510(k) clearance under submission number K990326, sponsored by Radionics Software Applications, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1999-03-04.
- Submission: K990326
- Applicant / Sponsor: Radionics Software Applications, Inc.
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 1999-03-04
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.