Clearance Summary
STD-228 SPECTRAL TREND DISPLAY received FDA 510(k) clearance under submission number K871480, sponsored by Grass-Telefactor Product Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1987-05-01.
- Submission: K871480
- Applicant / Sponsor: Grass-Telefactor Product Group
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1420
- Decision date: 1987-05-01
Classification & Regulation
This clearance is catalogued under FDA product code GWS and 21 CFR 882.1420, within the Neurology review panel as a Class I device.