Device |
non-invasive central venous manometer |
Regulation Description |
Venous blood pressure manometer. |
Definition |
Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology. |
Physical State |
display unit, sensor cable, and adhesive sensor patches |
Technical Method |
Uses near infrared spectroscopy (NIRS) technology to measure blood flow between the neck location and the reference location |
Target Area |
Applied to skin on neck to measure CVP |
Regulation Medical Specialty |
Cardiovascular |
Review Panel |
Cardiovascular |
Product Code | PFA |
Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
Submission Type |
510(k)
|
Regulation Number |
870.1140
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |