• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name ventilator, emergency, powered (resuscitator)
510(k) Number K173373
Device Name SafeT T-Piece Resuscitator
Applicant
Ventlab, LLC
2710 Northridge Drive NW - Suite A
Grand Rapids,  MI  49544
Applicant Contact Rob Yamashita
Correspondent
Ventlab, LLC
2710 Northridge Drive 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
-
-