• 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 system, imaging, pulsed echo, ultrasonic
510(k) Number K161968
Device Name MicrUs
Dariaus ir Gireno str.42
Vilnius,  LT LT-02189
Applicant Contact Yury Sokolov
Medical Imaging Innovations
Dariaus ir Gireno str. 42
Vilnius,  LT
Correspondent Contact Yury Sokolov
Regulation Number892.1560
Classification Product Code
Subsequent Product Code
Date Received07/18/2016
Decision Date 11/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No