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510(k) K132759

VENTRAIN by Dolphys Medical B.V. — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2014
Date Received
September 4, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

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