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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 K173373
Device Name SafeT T-Piece Resuscitator
Applicant
Ventlab, LLC
2710 Northridge Dr. NW - Suite A
Grand Rapids,  MI  49544
Applicant Contact Rob Yamashita
Correspondent
Ventlab, LLC
2710 Northridge Dr. NW - Suite A
Grand Rapids,  MI  49544
Correspondent Contact Rob Yamashita
Regulation Number868.5925
Classification Product Code
BTL  
Date Received10/27/2017
Decision Date 11/16/2018
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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