• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K122583
Device Name UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM
Original Applicant
SAMSUNG MEDISON CO., LTD
42, teheran-ro 108-gil
gangnam-gu
seoul,  KS
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received08/24/2012
Decision Date 09/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
-
-