Ototronix L L C

FDA Filings

This page includes the latest FDA filings for Ototronix L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012118649
FEI Number3012118649
NameOtotronix, LLC (Minnesota)
Owner & OperatorOtotronix, LLC
Contact Address5000 Township Parkway
Saint Paul MN 55110 US
Official Correspondent
  • Ravinder K Diamond
  • x-877-4104327-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5000 Township Pkwy
White Bear Township, MN 55110 US
Establishment Type
  • Remanufacture Medical Device
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
OTOTRONIX, LLC
MAXUM System2020-10-28
OTOTRONIX, LLC
MAXUM SYSTEM2016-05-03
OTOTRONIX, LLC
SOUNDTECH DIRECT AND MAXUM2016-03-22
OTOTRONIX, LLC
MAXUM2015-05-04
Ototronix, LLC (Minnesota) [Ototronix, LLC]
Nystagram2014-11-11
Ototronix, LLC (Minnesota) [Ototronix, LLC]
ProCem2014-07-25
OTOTRONIX, LLC
PROCEM2014-06-19
OTOTRONIX, LLC
MAXUM2013-09-13
OTOTRONIX, LLC
NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM2013-04-26
OTOTRONIX, LLC
MAXUM SYSTEM2012-05-10
OTOTRONIX, LLC
MAXUM SYSTEM2011-07-15
Ototronix, LLC (Minnesota) [Ototronix, LLC]
Cement2011-05-02
OTOTRONIX, LLC
MAXUM SYSTEM2011-04-08
Ototronix, LLC (Minnesota) [Ototronix, LLC]
OTOGRAM2011-03-03
Ototronix, LLC (Minnesota) [Ototronix, LLC]
OTOGRAM2011-03-03
Ototronix, LLC (Minnesota) [Ototronix, LLC]
OTOGRAM2011-03-03
Ototronix, LLC (Minnesota) [Ototronix, LLC]
OTOGRAM2011-03-03
Ototronix, LLC (Minnesota) [Ototronix, LLC]
B280 Series Hearing Aid2011-03-03
Ototronix, LLC (Minnesota) [Ototronix, LLC]
B180 Series Hearing Aid2011-03-03
Ototronix, LLC (Minnesota) [Ototronix, LLC]
AMR Series Hearing Aid2011-03-03
Ototronix, LLC (Minnesota) [Ototronix, LLC]
AMQ Series Hearing Aid2011-03-03
OTOTRONIX, LLC
MAXUM SYSTEM2011-03-02
OTOTRONIX, LLC
MAXUM SYSTEM2010-11-05
OTOTRONIX, LLC
MAXUM SYSTEM2010-09-30
OTOTRONIX, LLC
MAXUM SYSTEM2010-09-10
Ototronix, LLC (Minnesota) [Ototronix, LLC]
Maxum2010-03-03
OTOTRONIX, LLC
MAXUM SYSTEM2009-10-08
OTOTRONIX, LLC
SOUNDTEC DIRECT IPCA SYSTEM2002-09-04
OTOTRONIX, LLC
SOUNDTEC DIRECT SYSTEM2001-09-07

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