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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 K172875
Device Name Astral 100/150
Applicant
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista,  AU 2153
Applicant Contact Peter Jennings
Correspondent
Resmed Corp (Registration Number: 3007573469)
9001 Spectrum Center Boulevard
San Diego,  CA  92123
Correspondent Contact Sheila Bruschi
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
NOU  
Date Received09/21/2017
Decision Date 04/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT02683772
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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