Cleared Traditional

EASYCARE ONLINE

K132371 · Resmed, Ltd. · Anesthesiology
Nov 2013
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K132371 is an FDA 510(k) clearance for the EASYCARE ONLINE, a Ventilator, Continuous, Non-life-supporting (Class II — Special Controls, product code MNS), submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on November 22, 2013, 115 days after receiving the submission on July 30, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K132371 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2013
Decision Date November 22, 2013
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNS — Ventilator, Continuous, Non-life-supporting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895