Cleared Traditional

TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC

K974751 · General Hearing Instruments, Inc. · Ear, Nose, Throat

Mar 1998

Decision

77d

Days

Class 1

Risk

About This 510(k) Submission

K974751 is an FDA 510(k) clearance for the TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC, a Hearing Aid, Air-conduction, Prescription (Class I — General Controls, product code ESD), submitted by General Hearing Instruments, Inc. (Harahan, US). The FDA issued a Cleared decision on March 6, 1998, 77 days after receiving the submission on December 19, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K974751 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 1997
Decision Date	March 06, 1998
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

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.