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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K121374
Device Name ZI BLOWER
Original Applicant
DESHUM MEDICAL
5 timber lane
north reading,  MA  01864
Original Contact maureen o'connell
Regulation Number868.5905
Classification Product Code
BZD  
Date Received05/07/2012
Decision Date 02/22/2013
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
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