FDA.reportPublic FDA data

Ototronix, LLC (Minnesota)

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121186493012118649Ototronix, LLC (Minnesota)1N2026-01-015000 Township Pkwy White Bear Township MN US 55110

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1926591337177002P010023SOUNDTEC DIRECT SYSTEMMPV2001-09-07
1926591143787564K140644PROCEMNEA2014-06-19
1926591720666350K130201NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEMGWN2013-04-26
1926591913429334K070118OTOGRAM, CA3350EWO2007-03-07
1926591709139966K041853OTOGRAMETW2004-09-03
1926591003124989K003567SERENOCEM, MODEL BC 010NEA2001-02-12
1926591787903874

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NEA22014-06-19
GWN12013-04-26
EWO12007-03-07
ETW12004-09-03
MPV 12001-09-07