Cleared Traditional

MIRAGE ECHO

K090490 · ResMed Corp · Anesthesiology
May 2009
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K090490 is an FDA 510(k) clearance for the MIRAGE ECHO, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (Poway, US). The FDA issued a Cleared decision on May 6, 2009, 70 days after receiving the submission on February 25, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K090490 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2009
Decision Date May 06, 2009
Days to Decision 70 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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