Clearance Summary
PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST received FDA 510(k) clearance under submission number K091163, sponsored by Fiab Spa. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2009-07-22.
- Submission: K091163
- Applicant / Sponsor: Fiab Spa
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 2009-07-22
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.