Cleared Traditional

Astral 100/150

K152068 · Resmed, Ltd. · Anesthesiology
May 2016
Decision
294d
Days
Class 2
Risk

About This 510(k) Submission

K152068 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 May 13, 2016, 294 days after receiving the submission on July 24, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K152068 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2015
Decision Date May 13, 2016
Days to Decision 294 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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