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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 K102513
Device Name S9 VPAP ST WITH H5I
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 Number868.5905
Classification Product Code
BZD  
Date Received09/01/2010
Decision Date 01/05/2011
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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