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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, Facility Use
510(k) Number K151901
Device Name AirView
Applicant
RESMED LTD.
1 ELIZABETH MACARTHUR DRIVE
BELLA VISTA,  AU 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
CBK  
Date Received07/10/2015
Decision Date 11/05/2015
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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