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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 K152810
Device Name DeVilbiss DV6WM Wireless Modem
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 Paul Dryden
Regulation Number868.5905
Classification Product Code
BZD  
Date Received09/28/2015
Decision Date 01/21/2016
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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