Clearance Summary
OLYMPUS NEUROSCOPE, MODELS S-1349/1, S-1349/2, S-1349/3 AND S-1349/4 received FDA 510(k) clearance under submission number K020507, sponsored by Olympus Winter & Ibe GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-10-08.
- Submission: K020507
- Applicant / Sponsor: Olympus Winter & Ibe GmbH
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1480
- Decision date: 2002-10-08
Classification & Regulation
This clearance is catalogued under FDA product code GWG and 21 CFR 882.1480, within the Neurology review panel as a Class II device.