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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 K033914
Device Name OXYGEN DIVERTER VALVE
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 Received12/18/2003
Decision Date 04/22/2004
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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