Cleared Traditional

HemoSphere Advanced Monitor, HemoSphere ClearSight Module

K221833 · Edwards Lifesciences, LLC · Cardiovascular
Nov 2022
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K221833 is an FDA 510(k) clearance for the HemoSphere Advanced Monitor, HemoSphere ClearSight Module, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 7, 2022, 137 days after receiving the submission on June 23, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K221833 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2022
Decision Date November 07, 2022
Days to Decision 137 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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