Cleared Traditional

HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)

K221704 · Edwards Lifesciences, LLC · Cardiovascular
Nov 2022
Decision
162d
Days
Class 2
Risk

About This 510(k) Submission

K221704 is an FDA 510(k) clearance for the HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 22, 2022, 162 days after receiving the submission on June 13, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K221704 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2022
Decision Date November 22, 2022
Days to Decision 162 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

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