Definition: Measures The Central Venous Blood Pressure (CVP) Non-invasively At The Superior Vena Cava (right Heart) Based On Near Infrared Spectroscopy (NIRS) Technology.
| Device Type ID | 963 |
| Device Name | Non-invasive Central Venous Manometer |
| 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 Description | Venous Blood Pressure Manometer. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1140 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PFA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 963 |
| Device | Non-invasive Central Venous Manometer |
| Product Code | PFA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Venous Blood Pressure Manometer. |
| CFR Regulation Number | 870.1140 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MESPERE LIFESCIENCES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |