Clearance Summary
E-MITT (CONDUCTIVE HAND COVER) received FDA 510(k) clearance under submission number K883804, sponsored by The Institute For Technology Development. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-07-31.
- Submission: K883804
- Applicant / Sponsor: The Institute For Technology Development
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1720
- Decision date: 1989-07-31
Classification & Regulation
This clearance is catalogued under FDA product code EAT and 21 CFR 872.1720, within the Dental review panel as a Class II device.