De Novo DEN100025

Device: WIDEXLINK IN CLEAR SERIES HEARING AIDS
Contact: francis kuk
De Novo number: DEN100025
Product code: OSM
Regulation: 874.3305
Classification name: hearing aid, air-conduction with wireless technology, prescription
Decision: granted (DENG)
Decision date: 2011-03-31
Date received: 2010-10-13
Classification advisory: Ear Nose & Throat
Review advisory: Ear Nose & Throat
Type: Post-NSE

Current FDA Classification#

Product code: OSM
Device name: Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Medical specialty: Ear, Nose, Throat
Device class: 2
Regulation: 874.3305
Implant: N
Life sustain/support: N

Primary DI, Device, Company table
Primary DI	Device	Company	Published
05706069476118	Coselgi	Widex A/S	2016-09-01
05706069476552	Coselgi	Widex A/S	2016-09-01
05706069476545	Coselgi	Widex A/S	2016-09-01
05706069476460	Coselgi	Widex A/S	2016-09-01
05706069476453	Coselgi	Widex A/S	2016-09-01
05706069476378	Coselgi	Widex A/S	2016-09-01
05706069476361	Coselgi	Widex A/S	2016-09-01
05706069476262	Coselgi	Widex A/S	2016-09-01
05706069476255	Coselgi	Widex A/S	2016-09-01
05706069476125	Coselgi	Widex A/S	2016-09-01
05706069475265	Coselgi	Widex A/S	2016-09-01
05706069476026	Coselgi	Widex A/S	2016-09-01
05706069476019	Coselgi	Widex A/S	2016-09-01
05706069475814	Coselgi	Widex A/S	2016-09-01
05706069475807	Coselgi	Widex A/S	2016-09-01
05706069475715	Coselgi	Widex A/S	2016-09-01
05706069475708	Coselgi	Widex A/S	2016-09-01
05706069475616	Coselgi	Widex A/S	2016-09-01
05706069475609	Coselgi	Widex A/S	2016-09-01
05706069475272	Coselgi	Widex A/S	2016-09-01