Clearance Summary
PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES received FDA 510(k) clearance under submission number K033730, sponsored by Pmt Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2004-08-03.
- Submission: K033730
- Applicant / Sponsor: Pmt Corp.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1330
- Decision date: 2004-08-03
Classification & Regulation
This clearance is catalogued under FDA product code GZL and 21 CFR 882.1330, within the Neurology review panel as a Class II device.