Cleared Traditional

AirFit F20

K153563 · Resmed, Ltd. · Anesthesiology
May 2016
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K153563 is an FDA 510(k) clearance for the AirFit F20, 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 May 13, 2016, 151 days after receiving the submission on December 14, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K153563 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2015
Decision Date May 13, 2016
Days to Decision 151 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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