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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 K143677
Device Name DeVilbiss Intellipap2/DeVilbiss BLUE
Applicant
DeVilbiss Healthcare, LLC
100 DeVilbiss Drive
Somerset,  PA  15501
Applicant Contact Betty Miller
Correspondent
DeVilbiss Healthcare, LLC
100 DeVilbiss Drive
Somerset,  PA  15501
Correspondent Contact Betty Miller
Regulation Number868.5905
Classification Product Code
BZD  
Date Received12/24/2014
Decision Date 09/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT01797705
Reviewed by Third Party No
Combination Product No
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