FDA.reportPublic FDA data

510(k) K952057

Device
LISTENAIDER II
Applicant
NATIONAL HEARING AID DIST., INC.
510(k) number
K952057
Product code
LZI  
Decision
Substantially Equivalent (SESE)
Decision date
1995-06-21
Date received
1995-05-02
Regulation
874.3320
Classification name
Device, Assistive Listening
Medical specialty
Ear Nose & Throat
Review panel
Ear Nose & Throat
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY A MCLAUGHLIN
Address
301 U.S. Rt. 1 Scarborough ME US 04074 04074

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LZI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K043090EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMSPhonic Ear, Inc.2004-12-23
K970974WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPERWilliams Sound, LLC1997-05-02
K970340AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIERBellab1997-03-26
K954748POCKETALKER PROWilliams Sound, LLC1995-11-22
K934805HEARITJe Liss & Co., Inc.1994-02-07
K904755ACOUSTIQ LISTENING DEVICEKrueger Laboratories1991-01-29

Legacy Summary#

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

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