| Device |
adjunctive hemodynamic indicator with decision point for military use |
| Regulation Description |
Adjunctive hemodynamic indicator with decision point. |
| Definition |
An adjunctive hemodynamic indicator with decision point is a device that identifies and monitors hemodynamic condition(s) of interest and provides notifications at a clinically meaningful decision point. This device is intended to be used adjunctively along with other monitoring and patient information. The device is intended for use by the Military. |
| Physical State |
Uses analysis of patient data and/or measured vital signs to detect current signs of a hemodynamic condition. |
| Technical Method |
Software |
| Target Area |
Cardiovascular system |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | SAR |
|---|
| Premarket Review |
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.2220
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
