• 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 tube, tracheal (w/wo connector)
510(k) Number K152438
Device Name ETView VivaSight-SL (TVT) system
Applicant
ETVIEW LTD.
M.P MISGAV
MISGAV BUSINESS PARK,  IL 201790
Applicant Contact YORAM LEVY
Correspondent
QSITE
31 HAAVODA ST.
BINYAMINA,  IL 30500
Correspondent Contact YORAM LEVY
Regulation Number868.5730
Classification Product Code
BTR  
Date Received08/27/2015
Decision Date 02/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-