Karen O'Leary
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3042941992 | 3042941992 | Karen O'Leary | 1 | N | 2026-01-01 | 17200 Laguna Canyon Rd Irvine CA US 92618 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 345547 | 1775259275 | K140312 | EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM | DXN | 2014-06-13 |
| 345547 | 1757169437 | K122381 | NEXFIN MODEL 2 | DXN | 2013-04-22 |
| 345547 | 1156904780 | K072049 | CONTINUOUS NON-INVASIVE CARDIAC OUTPUT AND BLOOD PRESSURE MONITOR WITH REAL-TIME HEMODYNAMICS | DXN | 2007-11-29 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DXN | 3 | 2014-06-13 |