Cleared Traditional

AirFit F20

K170924 · Resmed, Ltd. · Anesthesiology
Jan 2018
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K170924 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 January 3, 2018, 280 days after receiving the submission on March 29, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K170924 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2017
Decision Date January 03, 2018
Days to Decision 280 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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