Non-Invasive Central Venous Manometer

PFA · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1140

Classification

FDA Product Code: PFA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.1140
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

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

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown