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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 K122715
Device Name STELLAR 150
Applicant
RESMED GERMANY INC.
9001 SPECTRUMA CENTER
BOULEVARD
SAN DIEGO,  CA  92123
Applicant Contact JIM CASSI
Correspondent
RESMED GERMANY INC.
9001 SPECTRUMA CENTER
BOULEVARD
SAN DIEGO,  CA  92123
Correspondent Contact JIM CASSI
Regulation Number868.5895
Classification Product Code
MNT  
Date Received09/05/2012
Decision Date 06/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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