Cleared Traditional

SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS

K943380 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Jan 1995

Decision

176d

Days

Class 1

Risk

About This 510(k) Submission

K943380 is an FDA 510(k) clearance for the SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Siemens Hearing Instruments, Inc. (Piscataway, US). The FDA issued a Cleared decision on January 5, 1995, 176 days after receiving the submission on July 13, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K943380 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 1994
Decision Date	January 05, 1995
Days to Decision	176 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

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.