• 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 gastroscope and accessories, flexible/rigid
510(k) Number K180911
Device Name Visura Technologies TEECAD System
Visura Technologies, LLC
9337 Harding Avenue
Evanston,  IL  60203
Applicant Contact Eric Sandberg
Valleygrey Enterprise
396 N. Whisman Rd.
Mountain View,  CA  94043
Correspondent Contact Gina Correa
Regulation Number876.1500
Classification Product Code
Subsequent Product Code
Date Received04/06/2018
Decision Date 06/20/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No