Cleared Traditional

S9 WANDA VPAP ST

K140159 · Resmed, Ltd. · Anesthesiology
Jun 2014
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K140159 is an FDA 510(k) clearance for the S9 WANDA VPAP ST, 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 June 17, 2014, 146 days after receiving the submission on January 22, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K140159 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2014
Decision Date June 17, 2014
Days to Decision 146 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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