Clearance Summary
TIGER PULSE received FDA 510(k) clearance under submission number K830325, sponsored by Bertone & Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1983-03-01.
- Submission: K830325
- Applicant / Sponsor: Bertone & Assoc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1340
- Decision date: 1983-03-01
Classification & Regulation
This clearance is catalogued under FDA product code GZK and 21 CFR 882.1340, within the Neurology review panel as a Class II device.