Cleared Traditional

SIEMENS MODEL TRITON 3004 B

K923380 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Aug 1992

Decision

40d

Days

Class 1

Risk

About This 510(k) Submission

K923380 is an FDA 510(k) clearance for the SIEMENS MODEL TRITON 3004 B, 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 August 18, 1992, 40 days after receiving the submission on July 9, 1992. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K923380 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 1992
Decision Date	August 18, 1992
Days to Decision	40 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.