Cleared Traditional

SWIFT AIR

K132013 · Resmed, Ltd. · Anesthesiology
Oct 2013
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K132013 is an FDA 510(k) clearance for the SWIFT AIR, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on October 21, 2013, 112 days after receiving the submission on July 1, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K132013 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2013
Decision Date October 21, 2013
Days to Decision 112 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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