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 K191115
Device Name RS85 Diagnostic Ultrasound System
Applicant
Samsung Medison Co., Ltd
3366 Hanseo-ro,Nam-myeon
Hongcheon-gun,  KR 25108
Applicant Contact Ji Yea Lee
Correspondent
Samsung Medison Co., Ltd
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun, Gangwon-do,  KR 25108
Correspondent Contact Ji Yea Lee
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/26/2019
Decision Date 06/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-