Clearance Summary
GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM) received FDA 510(k) clearance under submission number K945689, sponsored by Calmed 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 1995-02-08.
- Submission: K945689
- Applicant / Sponsor: Calmed Technology, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1050
- Decision date: 1995-02-08
Classification & Regulation
This clearance is catalogued under FDA product code EWO and 21 CFR 874.1050, within the Ear, Nose, Throat review panel as a Class II device.