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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K251657
Device Name Personalized Therapy Comfort Settings (PTCS)
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 Number868.5905
Classification Product Code
BZD  
Date Received05/30/2025
Decision Date 12/05/2025
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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