Clearance Summary
MODEL 7320 VISUAL STIMULATOR received FDA 510(k) clearance under submission number K781461, sponsored by Life-Tech Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1978-11-08.
- Submission: K781461
- Applicant / Sponsor: Life-Tech Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1890
- Decision date: 1978-11-08
Classification & Regulation
This clearance is catalogued under FDA product code GWE and 21 CFR 882.1890, within the Neurology review panel as a Class II device.