Cleared Traditional

Scone Mask

K180497 · Resmed, Ltd. · Anesthesiology
Jun 2018
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K180497 is an FDA 510(k) clearance for the Scone Mask, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed, Ltd. (Bella Vista Nsw 2153, AU). The FDA issued a Cleared decision on June 15, 2018, 109 days after receiving the submission on February 26, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K180497 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2018
Decision Date June 15, 2018
Days to Decision 109 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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