• 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 K100402
Device Name SITE-RITE VISION ULTRASOUND SYSTEM
Original Applicant
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city,  UT  84116
Original Contact kimberly geisler
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   LLZ  
Date Received02/16/2010
Decision Date 03/05/2010
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
Recalls CDRH Recalls
-
-