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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sv70 Ventilator
510(k) Number K103167
Device Name STELLAR 150
Applicant
Resmed Germany, Inc.
Fraunhoferstrasse 16
Martinsried,  DE D-82152
Applicant Contact SANDRA GRUNWALD
Correspondent
Resmed Germany, Inc.
Fraunhoferstrasse 16
Martinsried,  DE D-82152
Correspondent Contact SANDRA GRUNWALD
Regulation Number868.5895
Classification Product Code
MNT  
Date Received10/27/2010
Decision Date 03/01/2011
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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