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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 K152068
Device Name Astral 100/150
Applicant
Resmed, Ltd.
1 Elizabeth Macarthur Dr.
Bella Vista,  AU 2153
Applicant Contact Peter Jennings
Correspondent
Resmed Corp
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact Larissa D'Andrea
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received07/24/2015
Decision Date 05/13/2016
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
Recalls CDRH Recalls
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