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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
Original Applicant
9001 spectruma center
san diego,  CA  92123
Original Contact jim cassi
Regulation Number868.5895
Classification Product Code
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