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 Number: 3012118649
• FEI Number: 3012118649
• Name: Ototronix, LLC (Minnesota)
• Owner & Operator: Ototronix, LLC
• Contact Address: 5000 Township Parkway ; Saint Paul MN 55110 US
• Official Correspondent:
  • Ravinder K Diamond
  • x-877-4104327-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5000 Township Pkwy ; White Bear Township, MN 55110 US
• Establishment Type:
  • Remanufacture Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID M737M53031 Ototronix, LLC	MAXUM	2022-04-06
GUDID M737M31991 Ototronix, LLC	MAXUM	2022-04-06
GUDID M737M31101 Ototronix, LLC	MAXUM	2022-04-06
GUDID M737P97401 Ototronix, LLC	PROCEM	2020-12-10
GUDID M737P97301 Ototronix, LLC	PROCEM	2020-12-10
GUDID M737P97201 Ototronix, LLC	PROCEM	2020-12-10
GUDID M7379860041 Ototronix, LLC	PROCEM 986-004	2020-12-10
GUDID M7379860031 Ototronix, LLC	PROCEM 986-003	2020-12-10
GUDID M7379860021 Ototronix, LLC	PROCEM 986-002	2020-12-10
GUDID M7379860011 Ototronix, LLC	PROCEM 986-001	2020-12-10
PMA P010023S014 OTOTRONIX, LLC	MAXUM System	2020-10-28
PMA P010023S012 OTOTRONIX, LLC	MAXUM SYSTEM	2016-05-03
PMA P010023S013 OTOTRONIX, LLC	SOUNDTECH DIRECT AND MAXUM	2016-03-22
PMA P010023S011 OTOTRONIX, LLC	MAXUM	2015-05-04
PMN K130201 | GWN Ototronix, LLC (Minnesota) [Ototronix, LLC]	Nystagram	2014-11-11
PMN K140644 | NEA Ototronix, LLC (Minnesota) [Ototronix, LLC]	ProCem	2014-07-25
PMN K140644 OTOTRONIX, LLC	PROCEM	2014-06-19
PMA P010023S010 OTOTRONIX, LLC	MAXUM	2013-09-13
PMN K130201 OTOTRONIX, LLC	NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM	2013-04-26
PMA P010023S007 OTOTRONIX, LLC	MAXUM SYSTEM	2012-05-10
PMA P010023S009 OTOTRONIX, LLC	MAXUM SYSTEM	2011-07-15
PMN K003567 | NEA Ototronix, LLC (Minnesota) [Ototronix, LLC]	Cement	2011-05-02
PMA P010023S004 OTOTRONIX, LLC	MAXUM SYSTEM	2011-04-08
PMN K070118 | NAS Ototronix, LLC (Minnesota) [Ototronix, LLC]	OTOGRAM	2011-03-03
PMN K070118 | EWO Ototronix, LLC (Minnesota) [Ototronix, LLC]	OTOGRAM	2011-03-03
PMN K070118 | ETY Ototronix, LLC (Minnesota) [Ototronix, LLC]	OTOGRAM	2011-03-03
PMN K041853 | ETW Ototronix, LLC (Minnesota) [Ototronix, LLC]	OTOGRAM	2011-03-03
ESD Ototronix, LLC (Minnesota) [Ototronix, LLC]	B280 Series Hearing Aid	2011-03-03
ESD Ototronix, LLC (Minnesota) [Ototronix, LLC]	B180 Series Hearing Aid	2011-03-03
ESD Ototronix, LLC (Minnesota) [Ototronix, LLC]	AMR Series Hearing Aid	2011-03-03
ESD Ototronix, LLC (Minnesota) [Ototronix, LLC]	AMQ Series Hearing Aid	2011-03-03
PMA P010023S008 OTOTRONIX, LLC	MAXUM SYSTEM	2011-03-02
PMA P010023S006 OTOTRONIX, LLC	MAXUM SYSTEM	2010-11-05
PMA P010023S003 OTOTRONIX, LLC	MAXUM SYSTEM	2010-09-30
PMA P010023S005 OTOTRONIX, LLC	MAXUM SYSTEM	2010-09-10
PMN P010023 | MPV Ototronix, LLC (Minnesota) [Ototronix, LLC]	Maxum	2010-03-03
PMA P010023S002 OTOTRONIX, LLC	MAXUM SYSTEM	2009-10-08
PMA P010023S001 OTOTRONIX, LLC	SOUNDTEC DIRECT IPCA SYSTEM	2002-09-04
PMA P010023 OTOTRONIX, LLC	SOUNDTEC DIRECT SYSTEM	2001-09-07

Related Finance Registrations

NCAGE Code	68K79	OTOTRONIX, LLC
CAGE Code	68K79	OTOTRONIX, LLC
S.A.M. Registration	68K79 [833067478]	OTOTRONIX, LLC