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
1057216473
Device Listing 1057216473
Listing Summary
#
Listing key
1057216473
Premarket submission
K191372
Device
Lyra
Applicant
Interacoustics A/S
Product code
EWO
Decision date
2019-07-15
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
8932
9710051
3000254565
INTERACOUSTICS A/S
1
N
2026-01-01
Audiometer Alle 1 Middelfart Syddanmark DK 5500
176219
3011310592
3011310592
Brandon Bell
1
N
2026-01-01
10395 West 70th Street Eden Prairie MN US 55344