Cleared Traditional

EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS

K043090 · Phonic Ear, Inc. · Ear, Nose, Throat
Dec 2004
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K043090 is an FDA 510(k) clearance for the EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS, a Device, Assistive Listening (Class II — Special Controls, product code LZI), submitted by Phonic Ear, Inc. (Petaluma, US). The FDA issued a Cleared decision on December 23, 2004, 45 days after receiving the submission on November 8, 2004. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K043090 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2004
Decision Date December 23, 2004
Days to Decision 45 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code LZI — Device, Assistive Listening
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3320