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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 K123511
Device Name S9 VPAP TX
Applicant
RESMED LTD.
9001 SPECTRUM CENTER BLVD.
SAN DIEGO,  CA  92123
Applicant Contact JIM CASSI
Correspondent
RESMED LTD.
9001 SPECTRUM CENTER BLVD.
SAN DIEGO,  CA  92123
Correspondent Contact JIM CASSI
Regulation Number868.5895
Classification Product Code
MNS  
Date Received11/13/2012
Decision Date 03/21/2013
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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