PFA · Class II · 21 CFR 870.1140

FDA Product Code PFA: Non-invasive Central Venous Manometer

Measures The Central Venous Blood Pressure (cvp) Non-invasively At The Superior Vena Cava (right Heart) Based On Near Infrared Spectroscopy (nirs) Technology.

Leading manufacturers include Mespere Lifesciences, Inc..

2
Total
2
Cleared
84d
Avg days
2013
Since

FDA 510(k) Cleared Non-invasive Central Venous Manometer Devices (Product Code PFA)

2 devices
1–2 of 2
Cleared Aug 12, 2015
Central Venous Pressure System
K151776
Mespere Lifesciences, Inc.
Cardiovascular · 42d
Cleared Aug 22, 2013
CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
K131085
Mespere Lifesciences, Inc.
Cardiovascular · 126d

About Product Code PFA - Regulatory Context