Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 K162968
Device Name VORTRAN GO2VENT
Applicant
VORTRAN MEDICAL TECHNOLOGY 1, INC.
21 GOLDENLAND COURT, #100
SACRAMENTO,  CA  95834
Applicant Contact James Lee
Correspondent
VORTRAN MEDICAL TECHNOLOGY 1, INC.
21 GOLDENLAND COURT, #100
SACRAMENTO,  CA  95834
Correspondent Contact James Lee
Regulation Number868.5925
Classification Product Code
BTL  
Date Received10/24/2016
Decision Date 04/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-