Clearance Summary
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING INSTRUMENT received FDA 510(k) clearance under submission number K954038, sponsored by Argosy Electronics. 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 1995-09-18.
- Submission: K954038
- Applicant / Sponsor: Argosy Electronics
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1995-09-18
Classification & Regulation
This clearance is catalogued under FDA product code ESD and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.