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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 K140929
Device Name Z1 CPAP SYSTEM
Applicant
HUMAN DESIGN MEDICAL, LLC
5 TIMBER LANE
north reading,  MA  01864
Applicant Contact maureen o'connell
Correspondent
HUMAN DESIGN MEDICAL, LLC
5 TIMBER LANE
north reading,  MA  01864
Correspondent Contact maureen o'connell
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/09/2014
Decision Date 10/17/2014
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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