Cleared Traditional

S9 GREENHILLS

K140279 · Resmed, Ltd. · Anesthesiology
Jul 2014
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K140279 is an FDA 510(k) clearance for the S9 GREENHILLS, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed, Ltd. (San Diego, US). The FDA issued a Cleared decision on July 31, 2014, 178 days after receiving the submission on February 3, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K140279 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 2014
Decision Date July 31, 2014
Days to Decision 178 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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