Cleared Traditional

AirView

K151901 · Resmed, Ltd. · Anesthesiology
Nov 2015
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K151901 is an FDA 510(k) clearance for the AirView, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Resmed, Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on November 5, 2015, 118 days after receiving the submission on July 10, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K151901 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2015
Decision Date November 05, 2015
Days to Decision 118 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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