Cleared Traditional

AIRFIT N10

K132887 · Resmed, Ltd. · Anesthesiology
Dec 2013
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K132887 is an FDA 510(k) clearance for the AIRFIT N10, 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 December 20, 2013, 95 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 K132887 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2013
Decision Date December 20, 2013
Days to Decision 95 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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