FDA.reportPublic FDA data

SOTERIX MEDICAL,INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121824973012182497SOTERIX MEDICAL,INC.1Y2026-01-011480 US Highway 9 North, 204 Woodbridge NJ US 07095

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2080551709243581K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF2024-03-25
2080551101182801K192823MEGA-TMSGWF2021-08-13
2080551826732279K170291IontoDCEGJ2017-05-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GWF22024-03-25
EGJ12017-05-01

PMN#

IontoDC

2017-05-01

SOTERIX MEDICAL,INC.