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 K210068
Device Name HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
Applicant
Samsung Medison CO., LTD.
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun,  KR 25108
Applicant Contact Scully Kim
Correspondent
Samsung Medison CO., LTD.
3366, Hanseo-ro, Nam-myeon
Hongcheon-gun,  KR 25108
Correspondent Contact Scully Kim
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received01/11/2021
Decision Date 04/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-