SHUNTCHECK
NEURODX DEVELOPMENT LLC
NeuroDx Development LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004082659 | 3004082659 | NeuroDx Development LLC | 1 | N | 2020-04-25 | 115 E Ferry Rd Yardley PA US 19067 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 21400 | 1483461709 | K123554 | SHUNTCHECK | JXG | 2013-03-07 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JXG | 1 | 2013-03-07 |
PMN#
GUDID#
ShuntCheck III Software - ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
2018-10-18
ShuntCheck III DAQ - Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
2018-10-18
ShuntCheck Test Pack - ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container
2018-10-18