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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K080797
Device Name HUMIDAIRE 2I
Applicant
Resmed, Ltd.
14040 Danielson St.
Poway,  CA  92064 -6857
Applicant Contact DAVID D'CRUZ
Correspondent
Resmed, Ltd.
14040 Danielson St.
Poway,  CA  92064 -6857
Correspondent Contact DAVID D'CRUZ
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/20/2008
Decision Date 07/09/2008
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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