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 system, imaging, pulsed echo, ultrasonic
510(k) Number K161968
Device Name MicrUs
Applicant
TELEMED
Dariaus ir Gireno str.42
Vilnius,  LT LT-02189
Applicant Contact Yury Sokolov
Correspondent
Medical Imaging Innovations
Dariaus ir Gireno str. 42
Vilnius,  LT
Correspondent Contact Yury Sokolov
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
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
-
-