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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 K103167
Device Name STELLAR 150
Applicant
RESMED GERMANY INC.
FRAUNHOFERSTRASSE 16
MUNCHEN,  DE D-82152
Applicant Contact SANDRA GRUNWALD
Correspondent
RESMED GERMANY INC.
FRAUNHOFERSTRASSE 16
MUNCHEN,  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
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