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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 K113801
Device Name VPAP ADAPT
Applicant
RESMED CORP
9001 SPECTRUM CENTER BOULEVARD
KEARNY MESA,  CA  92123
Applicant Contact DAVID D D'CRUZ
Correspondent
RESMED CORP
9001 SPECTRUM CENTER BOULEVARD
KEARNY MESA,  CA  92123
Correspondent Contact DAVID D D'CRUZ
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/22/2011
Decision Date 05/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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