Clearance Summary
OPTI-AMP DC-POWERED received FDA 510(k) clearance under submission number K052060, sponsored by Intelligent Hearing Systems. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2005-08-31.
- Submission: K052060
- Applicant / Sponsor: Intelligent Hearing Systems
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1835
- Decision date: 2005-08-31
Classification & Regulation
This clearance is catalogued under FDA product code GWL and 21 CFR 882.1835, within the Neurology review panel as a Class II device.