Clearance Summary
ECHO-SCREEN T, TA, TD, TDA, TC received FDA 510(k) clearance under submission number K013977, sponsored by Fischer-Zoth Audiologic Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-06-14.
- Submission: K013977
- Applicant / Sponsor: Fischer-Zoth Audiologic Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1900
- Decision date: 2002-06-14
Classification & Regulation
This clearance is catalogued under FDA product code GWJ and 21 CFR 882.1900, within the Neurology review panel as a Class II device.