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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 K113288
Device Name VPAP ST-A
Applicant
RESMED LTD.
9001 SPECTRUM CENTER BLVD.
SAN DIEGO,  CA  92123
Applicant Contact DAVID D'CRUZ
Correspondent
RESMED LTD.
9001 SPECTRUM CENTER BLVD.
SAN DIEGO,  CA  92123
Correspondent Contact DAVID D'CRUZ
Regulation Number868.5895
Classification Product Code
MNS  
Date Received11/07/2011
Decision Date 03/29/2012
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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