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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
Predetermined Change
Control Plan Authorized		 No
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