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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 K161487
Device Name VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
Applicant
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista,  AU NSW 2153
Applicant Contact Jasjit Baveja
Correspondent
Resmed Corp
9001 Spectrum Center Boulevard
San Diego,  CA  92123
Correspondent Contact Larissa D'Andrea
Regulation Number868.5895
Classification Product Code
MNS  
Date Received05/31/2016
Decision Date 09/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT00733343
Reviewed by Third Party No
Combination Product No
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