Cleared Traditional

S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV

K160822 · Resmed, Ltd. · Anesthesiology

Sep 2016

Decision

169d

Days

Class 2

Risk

About This 510(k) Submission

K160822 is an FDA 510(k) clearance for the S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Resmed, Ltd. (Bella Vista, AU). The FDA issued a Cleared decision on September 9, 2016, 169 days after receiving the submission on March 24, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K160822 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 24, 2016
Decision Date	September 09, 2016
Days to Decision	169 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF