Cleared Traditional

Astral 100/150

K172875 · Resmed, Ltd. · Anesthesiology
Apr 2018
Decision
217d
Days
Class 2
Risk

About This 510(k) Submission

K172875 is an FDA 510(k) clearance for the Astral 100/150, 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 April 26, 2018, 217 days after receiving the submission on September 21, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K172875 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2017
Decision Date April 26, 2018
Days to Decision 217 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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