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 Doppler, Ultrasonic
510(k) Number K163121
Device Name SmartUs EXT-1M/3M
Applicant
TELEMED
DARIAUS IR GIRENO
STR.42
VILNIUS,  LT LT-02189
Applicant Contact YURY SOKOLOV
Correspondent
TELEMED
DARIAUS IR GIRENO
STR.42
VILNIUS,  LT LT-02189
Correspondent Contact YURY SOKOLOV
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received11/08/2016
Decision Date 08/10/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-