Clearance Summary
BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING received FDA 510(k) clearance under submission number K884937, sponsored by Grass-Telefactor Product Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-04-14.
- Submission: K884937
- Applicant / Sponsor: Grass-Telefactor Product Group
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6475
- Decision date: 1989-04-14
Classification & Regulation
This clearance is catalogued under FDA product code EEG and 21 CFR 872.6475, within the Dental review panel as a Class I device.