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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory To Continuous Ventilator (Respirator)
510(k) Number K261360
Device Name EasyCare Tx 2
Applicant
Resmed Corp
9001 Spectrum Blvd.
San Diego,  CA  92123
Applicant Contact Lawrence Kwan
Correspondent
Resmed Pty , Ltd.
1 Elizabeth Macarthur Dr.
Bella Vista,  AU 2153
Correspondent Contact Lawrence Kwan
Regulation Number868.5895
Classification Product Code
MOD  
Subsequent Product Codes
BZD   MNS  
Date Received04/24/2026
Decision Date 08/27/2026
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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