Hypotension Decision Assist Model HDA-OR2
Directed Systems Ltd
DIRECTED SYSTEMS LTD
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016585366 | 3016585366 | DIRECTED SYSTEMS LTD | 1 | N | 2026-01-01 | 47-51 Norfolk Street Cambridge Cambridgeshire GB CB1 2LD |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 238923 | 1682456103 | K212529 | Hypotension Decision Assist Model HDA-OR2 | DXG | 2021-11-23 |
| 238923 | 1264378081 | K190955 | Hypotension Decision Assist | DXG | 2019-11-27 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DXG | 2 | 2021-11-23 |
PMN#
Hypotension Decision Assist
Directed Systems Ltd
GUDID#
Hypotension Decision Assist (HDA) - Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters.HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.
2020-06-22
Hypotension Decision Assist (HDA) - Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device (SaMD) that is installed upon amedically-rated touch-screen tablet computer. HDA-OR2 connects to a multi-parameter patient monitor supplied by other manufacturers, fromwhich it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numericparameters. HDA-OR2 continually processes this data to display, in graphical charts and numeric format, vital signs data and derivedvariables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemicvascular resistance. HDA-OR2 compares MAP to user set targets to indicate when MAP is above or below the target range. It allowsthe user to mark the administration of vasopressors and volume challenges to the MAP trend.
2022-01-04