Cleared Traditional

ASTRAL VENTILATOR

K133868 · Resmed, Ltd. · Anesthesiology
Jun 2014
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K133868 is an FDA 510(k) clearance for the ASTRAL VENTILATOR, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on June 4, 2014, 166 days after receiving the submission on December 20, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K133868 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2013
Decision Date June 04, 2014
Days to Decision 166 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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