Clearance Summary
NERVE STIMULATOR, MOLEL NO. FB-800 received FDA 510(k) clearance under submission number K770987, sponsored by Output, 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 1977-06-14.
- Submission: K770987
- Applicant / Sponsor: Output, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5810
- Decision date: 1977-06-14
Classification & Regulation
This clearance is catalogued under FDA product code GZI and 21 CFR 882.5810, within the Neurology review panel as a Class II device.