Cleared Traditional

AIRSOFT F15

K132901 · Resmed, Ltd. · Anesthesiology
Jun 2014
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K132901 is an FDA 510(k) clearance for the AIRSOFT F15, 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 June 9, 2014, 266 days after receiving the submission on September 16, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K132901 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2013
Decision Date June 09, 2014
Days to Decision 266 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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