Cleared Traditional

ADDVANTAGE:TVC MARCON

K880284 · Richards Medical Co., Inc. · Ear, Nose, Throat

Feb 1988

Decision

32d

Days

Class 1

Risk

About This 510(k) Submission

K880284 is an FDA 510(k) clearance for the ADDVANTAGE:TVC MARCON, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on February 26, 1988, 32 days after receiving the submission on January 25, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K880284 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 1988
Decision Date	February 26, 1988
Days to Decision	32 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.