Cleared Traditional

POCKETALKER PRO

K954748 · Williams Sound, LLC · Ear, Nose, Throat
Nov 1995
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K954748 is an FDA 510(k) clearance for the POCKETALKER PRO, a Device, Assistive Listening (Class II — Special Controls, product code LZI), submitted by Williams Sound, LLC (Eden Prairie, US). The FDA issued a Cleared decision on November 22, 1995, 37 days after receiving the submission on October 16, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K954748 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1995
Decision Date November 22, 1995
Days to Decision 37 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

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

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