Device |
adjunctive hemodynamic indicator with decision point |
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. |
Physical State |
Software |
Technical Method |
Uses analysis of patient data and/or measured vital signs to detect current signs of a hemodynamic condition. |
Target Area |
Cardiovascular system |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | QNV |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
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 |