Clearance Summary
BRAEGEN EEG TRANSMITTER/RECEIVER SYS received FDA 510(k) clearance under submission number K811093, sponsored by Electro-Bio-Medical Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1981-05-05.
- Submission: K811093
- Applicant / Sponsor: Electro-Bio-Medical Services, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1855
- Decision date: 1981-05-05
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.