FDA.reportPublic FDA data

510(k) K091682

Device
LSVT C OR LSVT COMPANION, MODEL V.1
Applicant
LSVT GLOBAL, LLC
510(k) number
K091682
Product code
LEZ  
Decision
Substantially Equivalent (SESE)
Decision date
2009-08-20
Date received
2009-06-10
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
DAVID H MCFARLAND
Address
6900 E Sunrise Dr. Suite 120 #241 Tucson AZ US 85750 85750

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LEZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K982396VISIVOX, MODEL V-2Rsq, LLC1998-09-14
K802870RION ELECTRO-PALATOGRAPH MODEL DP-01Kindel & Anderson1980-12-17

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases