FDA.reportPublic FDA data

Capsule Tech Inc.

Matched from indexed company URL: CAPSULE TECH INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30066483203006648320Capsule Tech Inc.1Y2020-04-25300 Brickstone Square Suite 203 Andover MA US 01810

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
921511395806671K183638SmartLinx Vitals Plus Patient Monitoring SystemMWI2019-04-17
921511780819900K180734SmartLinx Vitals Plus Patient Monitoring SystemMWI2018-08-08
921511369549798K171751SmartLinx 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
921511945661796K151071SmartLinx 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
MWI42019-04-17

PMN#