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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
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