Cleared Traditional

K952057 - LISTENAIDER II
(FDA 510(k) Clearance)

K952057 · National Hearing Aid Dist., Inc. · Ear, Nose, Throat

Jun 1995

Decision

50d

Days

Class 2

Risk

K952057 is an FDA 510(k) clearance for the LISTENAIDER II. This device is classified as a Device, Assistive Listening (Class II — Special Controls, product code LZI).

Submitted by National Hearing Aid Dist., Inc. (Scarborough, US). The FDA issued a Cleared decision on June 21, 1995, 50 days after receiving the submission on May 2, 1995.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number	K952057 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 1995
Decision Date	June 21, 1995
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement