Cleared Traditional

Menai System

K160836 · Resmed, Ltd. · Anesthesiology
Dec 2016
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K160836 is an FDA 510(k) clearance for the Menai System, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed, Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on December 15, 2016, 265 days after receiving the submission on March 25, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K160836 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2016
Decision Date December 15, 2016
Days to Decision 265 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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