Cleared Traditional

SERIES MCAXX (MODEL 851) ITE HEARING AID

K903583 · Maico Hearing Instruments, Inc. · Ear, Nose, Throat

Oct 1990

Decision

62d

Days

Class 1

Risk

About This 510(k) Submission

K903583 is an FDA 510(k) clearance for the SERIES MCAXX (MODEL 851) ITE 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 October 9, 1990, 62 days after receiving the submission on August 8, 1990. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K903583 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 1990
Decision Date	October 09, 1990
Days to Decision	62 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.