FDA.reportPublic FDA data

Asim Nigam

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036303873003630387Asim Nigam1N2026-01-01222 Jacobs St Cambridge MA US 02141
30036871893003687189Asim Nigam1N2026-01-01222 Jacobs Street Cambridge MA US 02141

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3107611230545298K213335Capsule Surveillance SystemMWI2022-01-14
3107611900080575K210204Capsule Vitals Plus Patient Monitoring SystemMWI2021-10-19
907451866058310K190624EarlyVue VS30DSJ2019-10-27
3107611517928810K183638SmartLinx Vitals Plus Patient Monitoring SystemMWI2019-04-17
3107611479046126K180734SmartLinx Vitals Plus Patient Monitoring SystemMWI2018-08-08
3107611921620621K171751SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature ModuleMWI2017-10-24
3107611716068080K151071SmartLinx Vitals Plus Patient Monitoring SystemMWI2015-09-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MWI62022-01-14
DSJ12019-10-27