Clearance Summary
POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN received FDA 510(k) clearance under submission number K970880, sponsored by Micro-Ear Technology, Inc.. 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 1997-06-06.
- Submission: K970880
- Applicant / Sponsor: Micro-Ear Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1997-06-06
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.