Cleared Traditional

MODEL P20/P21 IN-THE-EAR HEARING AID

K882692 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Jul 1988

Decision

17d

Days

Class 1

Risk

About This 510(k) Submission

K882692 is an FDA 510(k) clearance for the MODEL P20/P21 IN-THE-EAR HEARING AID, 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 July 15, 1988, 17 days after receiving the submission on June 28, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K882692 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 28, 1988
Decision Date	July 15, 1988
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

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.