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Non-Invasive Central Venous Manometer

FDA product code PFA · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1140
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2013-08-22 – 2013-08-22

Measures the central venous blood pressure (CVP) non-invasively at the superior vena cava (right heart) based on near infrared spectroscopy (NIRS) technology.

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