510(k) K982396

Device: VISIVOX, MODEL V-2
Applicant: RSQ, LLC.
510(k) number: K982396
Product code: LEZ
Decision: Substantially Equivalent (SESE)
Decision date: 1998-09-14
Date received: 1998-07-09
Regulation: 510(k) Premarket Notification
Classification name: Aids, Speech Training For The Hearing Impaired (ac-powered And Patient-contact)
Medical specialty: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Review panel: Ear Nose & Throat
Device class: U
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DORIS DRUCKER
Address: 636 Wellesley Dr. Claremont CA US 91711 91711

Source Documents#

Other 510(k) Records For Product Code LEZ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K091682	LSVT C OR LSVT COMPANION, MODEL V.1	Lsvt Global, LLC	2009-08-20
K802870	RION ELECTRO-PALATOGRAPH MODEL DP-01	Kindel & Anderson	1980-12-17

Legacy Summary#

summary

FDA Review#

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