Cleared Traditional

Juno VPAP ST-A

K161492 · Resmed, Ltd. · Anesthesiology

Jan 2017

Decision

232d

Days

Class 2

Risk

About This 510(k) Submission

K161492 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 Nsw 2153, AU). The FDA issued a Cleared decision on January 19, 2017, 232 days after receiving the submission on June 1, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number	K161492 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2016
Decision Date	January 19, 2017
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF