Cleared Traditional

Edwards Algorithm for Measurement of Blood Hemoglobin

K230612 · Edwards Lifesciences, LLC · Cardiovascular
Nov 2023
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K230612 is an FDA 510(k) clearance for the Edwards Algorithm for Measurement of Blood Hemoglobin, a Oximeter, Tissue Saturation (Class II — Special Controls, product code MUD), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on November 17, 2023, 256 days after receiving the submission on March 6, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K230612 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2023
Decision Date November 17, 2023
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MUD — Oximeter, Tissue Saturation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700