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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, facility use
510(k) Number K111116
Model 1505-9000-000, 1505-903-000
Device Name ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
Original Applicant
po box 7550
3030 ohmeda dr
madison,  WI  53707
Original Contact monica morrison
Regulation Number868.5895
Classification Product Code
Date Received04/21/2011
Decision Date 09/09/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls