Cleared Traditional

Masimo W1

K232512 · Masimo Corporation · Cardiovascular
Nov 2023
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K232512 is an FDA 510(k) clearance for the Masimo W1, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Masimo Corporation (Irvine, US). The FDA issued a Cleared decision on November 17, 2023, 91 days after receiving the submission on August 18, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K232512 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2023
Decision Date November 17, 2023
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340