Clearance Summary
OBT STEREOTACTIC SYSTEM received FDA 510(k) clearance under submission number K874693, sponsored by Tipal Instruments , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1988-03-11.
- Submission: K874693
- Applicant / Sponsor: Tipal Instruments , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 1988-03-11
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.