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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 K111148
Device Name S8 ASPEN WITH H4I PLUS
Applicant
ResMed Corp
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Applicant Contact DAVID D'CRUZ
Correspondent
ResMed Corp
9001 Spectrum Center Blvd.
San Diego,  CA  92123
Correspondent Contact DAVID D'CRUZ
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/22/2011
Decision Date 06/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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