Cleared Traditional

OPTI-AMP

K914876 · Intelligent Hearing Systems · Neurology
Jan 1992
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K914876 is an FDA 510(k) clearance for the OPTI-AMP, a Amplifier, Physiological Signal (Class II — Special Controls, product code GWL), submitted by Intelligent Hearing Systems (North Miami, US). The FDA issued a Cleared decision on January 10, 1992, 73 days after receiving the submission on October 29, 1991. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1835.

Submission Details

510(k) Number K914876 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1991
Decision Date January 10, 1992
Days to Decision 73 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement

Device Classification

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