Clearance Summary
ENVOYCEM, MODEL 1640 received FDA 510(k) clearance under submission number K080032, sponsored by Envoy Medical Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2008-02-28.
- Submission: K080032
- Applicant / Sponsor: Envoy Medical Corporation
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3275
- Decision date: 2008-02-28
Classification & Regulation
This clearance is catalogued under FDA product code NEA and 21 CFR 872.3275, within the Dental review panel as a Class II device.