Cleared Traditional

EasyCare Tx 2

K241939 · ResMed Corp · Anesthesiology
Sep 2024
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K241939 is an FDA 510(k) clearance for the EasyCare Tx 2, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on September 27, 2024, 87 days after receiving the submission on July 2, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K241939 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2024
Decision Date September 27, 2024
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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