Cleared Traditional

Juno VPAP ST-A

K153061 · Resmed, Ltd. · Anesthesiology

Apr 2016

Decision

175d

Days

Class 2

Risk

About This 510(k) Submission

K153061 is an FDA 510(k) clearance for the Juno VPAP ST-A, 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 April 13, 2016, 175 days after receiving the submission on October 21, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K153061 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 21, 2015
Decision Date	April 13, 2016
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF