Cleared Traditional

IMPULSE TVC (RICHARDS, OMNI, MARCON)

K881143 · Richards Medical Co., Inc. · Ear, Nose, Throat

May 1988

Decision

62d

Days

Class 1

Risk

About This 510(k) Submission

K881143 is an FDA 510(k) clearance for the IMPULSE TVC (RICHARDS, OMNI, 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 May 18, 1988, 62 days after receiving the submission on March 17, 1988. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K881143 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1988
Decision Date	May 18, 1988
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.