Ototronix L L C Minnesota

FDA Filings

This page includes the latest FDA filings for Ototronix L L C Minnesota. 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
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 K003567 | NEA Ototronix, LLC (Minnesota) [Ototronix, LLC]	Cement	2011-05-02
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
PMN P010023 | MPV Ototronix, LLC (Minnesota) [Ototronix, LLC]	Maxum	2010-03-03