Cleared Traditional

MAICO IN-THE-EAR MODEL RD-312 CIC

K950637 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Mar 1995

Decision

36d

Days

Class 1

Risk

About This 510(k) Submission

K950637 is an FDA 510(k) clearance for the MAICO IN-THE-EAR MODEL RD-312 CIC, 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 March 21, 1995, 36 days after receiving the submission on February 13, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K950637 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 1995
Decision Date	March 21, 1995
Days to Decision	36 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.