Cleared Traditional

VPAP Adapt SV, VPAP Tx, S9 VPAP Tx

K161487 · Resmed, Ltd. · Anesthesiology
Sep 2016
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K161487 is an FDA 510(k) clearance for the VPAP Adapt SV, VPAP Tx, S9 VPAP Tx, a Ventilator, Continuous, Non-life-supporting (Class II — Special Controls, product code MNS), submitted by Resmed, Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on September 9, 2016, 101 days after receiving the submission on May 31, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K161487 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2016
Decision Date September 09, 2016
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code MNS — Ventilator, Continuous, Non-life-supporting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895