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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K143603
Device Name Darlinghurst Vented, Darlinghurst NV-AAV
Applicant
RESMED LTD.
1 ELIZABETH MACARTHUR DR
BELLA VISTA,  AU 2153
Applicant Contact Jean-Nicholas Boudaud
Correspondent
RESMED CORP.
9001 SPECTRUM CENTER BOULEVARD
San Diego,  CA  92123
Correspondent Contact LARISSA D'ANDREA
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/18/2014
Decision Date 05/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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