ASCOM US, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008855170 | 3008855170 | ASCOM US, INC. | 1 | Y | 2026-01-01 | 300 Perimeter Park Dr Ste D Morrisville NC US 27560 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 236831 | 1132536333 | K180566 | Unite Connect for Clinical Systems | MSX | 2018-04-03 |
| 236831 | 1014015252 | K180430 | Digistat Smart Central | MSX | 2018-11-23 |
| 236831 | 1376661645 | K111215 | ASCOM MOBILE MONITORING GATEWAY (MMG) | MSX | 2011-07-05 |
| 236831 | 1853121234 | K103634 | ASCOM CLINICALCONNEX CARDIOMAX | MSX | 2011-02-23 |
| 236831 | 2030979417 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MSX | 4 | 2018-11-23 |