FDA.reportPublic FDA data

SOTERA WIRELESS

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096736453009673645SOTERA WIRELESS1N2026-01-015841 Edison Place Suite #140 Carlsbad CA US 92008

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1422851274709313K180472ViSi Mobile Monitoring SystemMHX2018-06-19
1422851582600551K152341ViSi Mobile Monitoring SystemMWI2015-12-14
1422851070775891K142827Visi Mobile Monitoring System, Visi Mobile Chest SensorMHX2015-07-20
1422851438597922K141496MULTI-PARAMETER MOBILE CAREGUIDE 4100 OXIMETERMUD2014-08-04
1422851609488231K133923MULTI-PARAMETER MOBILE CAREGUIDE 3100 OXIMETER WITH TABLETMUD2014-04-11
1422851271698124K122645MOBILE CAREGUIDE 2100 OXIMETERMUD2012-12-05
1422851143064646K113656CAREGUIDE OXIMETERMUD2012-07-26
1422851365711286K112478VISI MOBILE MONITORING SYSTEMMWI2012-03-22
1422851737937332

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MHX42018-06-19
MUD42014-08-04
MWI32015-12-14