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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Non-Life-Supporting
510(k) Number K161492
Device Name Juno VPAP ST-A
Applicant
Resmed, Ltd.
1 Elizabeth Macarthur Dr.
Bella Vista Nsw 2153,  AU 2153
Applicant Contact Jean-Nicolas Boudaud
Correspondent
Resmed Corp
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact Larissa D'Andrea
Regulation Number868.5895
Classification Product Code
MNS  
Date Received06/01/2016
Decision Date 01/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT02317042
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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