Cleared Traditional

SONATA U-01

K955702 · Electone, Inc. · Ear, Nose, Throat

Feb 1996

Decision

69d

Days

Class 1

Risk

About This 510(k) Submission

K955702 is an FDA 510(k) clearance for the SONATA U-01, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Electone, Inc. (Longwood, US). The FDA issued a Cleared decision on February 22, 1996, 69 days after receiving the submission on December 15, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K955702 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 1995
Decision Date	February 22, 1996
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	ESD — Hearing Aid, Air-conduction, Prescription
Device Class	Class I — General Controls
CFR Regulation	21 CFR 874.3300
Definition	An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.