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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 K251889
Device Name myAir
Applicant
Resmed Corp
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Applicant Contact Rose Malonzo
Correspondent
Resmed Corp
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact Rose Malonzo
Regulation Number868.5895
Classification Product Code
MNS  
Subsequent Product Codes
BZD   MNR  
Date Received06/20/2025
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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