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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, Minimal Ventilatory Support, Facility Use
510(k) Number K113640
Device Name STELLAR 150
Applicant
Resmed Germany, Inc.
9001 Spectruma Center
Boulevard
San Diego,  CA  92123
Applicant Contact DAVID D'CRUZ
Correspondent
Resmed Germany, Inc.
9001 Spectruma Center
Boulevard
San Diego,  CA  92123
Correspondent Contact DAVID D'CRUZ
Regulation Number868.5895
Classification Product Code
MNT  
Date Received12/09/2011
Decision Date 04/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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