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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 K053205
Device Name RES TRAXX DATA CENTER
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 Number868.5905
Classification Product Code
BZD  
Date Received11/16/2005
Decision Date 02/03/2006
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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