Cleared Traditional

AirFit N20

K161978 · Resmed, Ltd. · Anesthesiology
Nov 2016
Decision
122d
Days
Class 2
Risk

About This 510(k) Submission

K161978 is an FDA 510(k) clearance for the AirFit N20, 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 November 17, 2016, 122 days after receiving the submission on July 18, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K161978 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2016
Decision Date November 17, 2016
Days to Decision 122 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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