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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, Non-Life-Supporting
510(k) Number K251661
Device Name Mariana Minerva; Mariana Nimbus
Applicant
Resmed Pty , Ltd.
1 Elizabeth Macarthur Dr.
Bella Vista,  AU 2153
Applicant Contact Nerida Hunt
Correspondent
Resmed Pty , Ltd.
1 Elizabeth Macarthur Dr.
Bella Vista,  AU 2153
Correspondent Contact Nicole Wilson
Regulation Number868.5895
Classification Product Code
MNS  
Subsequent Product Code
BTT  
Date Received05/30/2025
Decision Date 02/23/2026
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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