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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K132759
Device Name VENTRAIN
Applicant
Dolphys Medical B.V.
De Lismortel 31
Eindhoven,  NL 5612ar
Applicant Contact FABIENNE PETERS
Correspondent
Dolphys Medical B.V.
De Lismortel 31
Eindhoven,  NL 5612ar
Correspondent Contact FABIENNE PETERS
Regulation Number868.5925
Classification Product Code
BTL  
Date Received09/04/2013
Decision Date 03/26/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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