Cleared Special

HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

K223127 · Edwards Lifeciences, LLC · Cardiovascular
Nov 2022
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K223127 is an FDA 510(k) clearance for the HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Edwards Lifeciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 7, 2022, 35 days after receiving the submission on October 3, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K223127 FDA.gov
FDA Decision Cleared SESE
Date Received October 03, 2022
Decision Date November 07, 2022
Days to Decision 35 days
Submission Type Special
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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