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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 K132606
Device Name S9 CRONULLA FOR HER
Applicant
RESMED LTD.
9001 SPECTRUM CENTER BLVD
KEARNY MESA,  CA  92123
Correspondent
RESMED LTD.
9001 SPECTRUM CENTER BLVD
KEARNY MESA,  CA  92123
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/20/2013
Decision Date 01/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01826513
Reviewed by Third Party No
Combination Product No
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