Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1184356067
Device Listing 1184356067
Listing Summary
#
Listing key
1184356067
Premarket submission
K180495
Device
Tinnitus Sound Generator Module
Applicant
GN Hearing A/S
Product code
KLW
Decision date
2018-11-30
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
5982
2182204
2182204
GN Hearing Care Corporation
1
Y
2026-01-01
5005 Dean Lakes Blvd Shakopee MN US 55379
5984
3003303986
3003303986
GN RESOUND CHINA, LTD.
1
N
2026-01-01
15 CHUANG XIN ROAD-CPA AREA XIAMEN Fujian CN 361006
5986
3005650109
3005650109
GN Hearing A/S
1
N
2026-01-01
LAUTRUPBJERG 7 BALLERUP Hovedstaden DK DK-2750
186139
3011927597
3011927597
Thomas Brockway
1
N
2026-01-01
5005 Dean Lakes Blvd Shakopee MN US 55379