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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 K031047
Device Name MIRAGE VISTA MASK
Applicant
RESMED LTD.
14040 DANIELSON ST.
POWAY,  CA  92064 -6857
Applicant Contact ROGER KOTTER
Correspondent
RESMED LTD.
14040 DANIELSON ST.
POWAY,  CA  92064 -6857
Correspondent Contact ROGER KOTTER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/02/2003
Decision Date 08/19/2003
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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