Cleared Traditional

INFINITY 252

K935019 · Siemens Hearing Instruments, Inc. · Ear, Nose, Throat

Sep 1994

Decision

322d

Days

Class 1

Risk

About This 510(k) Submission

K935019 is an FDA 510(k) clearance for the INFINITY 252, 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 September 7, 1994, 322 days after receiving the submission on October 20, 1993. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K935019 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 1993
Decision Date	September 07, 1994
Days to Decision	322 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.