Clearance Summary
VOCALTECH VOCAL FEEDBACK DEVICE received FDA 510(k) clearance under submission number K871590, sponsored by Vocaltech C/O Hogan & Hartson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1987-10-06.
- Submission: K871590
- Applicant / Sponsor: Vocaltech C/O Hogan & Hartson
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.5840
- Decision date: 1987-10-06
Classification & Regulation
This clearance is catalogued under FDA product code KTH and 21 CFR 874.5840, within the Ear, Nose, Throat review panel as a Class I device.