Cleared Traditional

MAICO IN-THE-EAR MODEL RD 201

K946253 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Jan 1995

Decision

38d

Days

Class 1

Risk

About This 510(k) Submission

K946253 is an FDA 510(k) clearance for the MAICO IN-THE-EAR MODEL RD 201, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Maico Hearing Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 30, 1995, 38 days after receiving the submission on December 23, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K946253 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1994
Decision Date	January 30, 1995
Days to Decision	38 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.