Clearance Summary
MODAC-XXXX INTENSIVE MONITORING OF EEG received FDA 510(k) clearance under submission number K860128, 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 1986-03-27.
- Submission: K860128
- Applicant / Sponsor: Grass-Telefactor Product Group
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1855
- Decision date: 1986-03-27
Classification & Regulation
This clearance is catalogued under FDA product code GYE and 21 CFR 882.1855, within the Neurology review panel as a Class II device.