Cleared Traditional

HEARIT

K934805 · Je Liss & Co., Inc. · Ear, Nose, Throat

Feb 1994

Decision

123d

Days

Class 2

Risk

About This 510(k) Submission

K934805 is an FDA 510(k) clearance for the HEARIT, a Device, Assistive Listening (Class II — Special Controls, product code LZI), submitted by Je Liss & Co., Inc. (Tucson, US). The FDA issued a Cleared decision on February 7, 1994, 123 days after receiving the submission on October 7, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number	K934805 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 1993
Decision Date	February 07, 1994
Days to Decision	123 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement