Cleared Traditional

WILLIAMS SOUND, PERSONAL FM, HEARING HELPER

K970665 · Williams Sound, LLC · Ear, Nose, Throat
May 1997
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K970665 is an FDA 510(k) clearance for the WILLIAMS SOUND, PERSONAL FM, HEARING HELPER, a Hearing Aid, Group And Auditory Trainer (Class II — Special Controls, product code EPF), submitted by Williams Sound, LLC (Eden Prairie, US). The FDA issued a Cleared decision on May 2, 1997, 70 days after receiving the submission on February 21, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3320.

Submission Details

510(k) Number K970665 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1997
Decision Date May 02, 1997
Days to Decision 70 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EPF — Hearing Aid, Group And Auditory Trainer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3320

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