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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Non-Life-Supporting
510(k) Number K051364
Device Name VPAP ADAPT
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 Number868.5895
Classification Product Code
MNS  
Date Received05/25/2005
Decision Date 08/16/2005
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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