Cleared Special

OPTI-AMP DC-POWERED

K052060 · Intelligent Hearing Systems · Neurology
Aug 2005
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K052060 is an FDA 510(k) clearance for the OPTI-AMP DC-POWERED, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Intelligent Hearing Systems (Miami, US). The FDA issued a Cleared decision on August 31, 2005, 33 days after receiving the submission on July 29, 2005. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K052060 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2005
Decision Date August 31, 2005
Days to Decision 33 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWL — Amplifier, Physiological Signal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1835