• 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, hypothermia, intravenous, cooling
510(k) Number K060308
Device Name COOLGARD 3000
Original Applicant
15770 laguna canyon, suite 150
irvine,  CA  92618
Original Contact kenneth a collins
Regulation Number870.5900
Classification Product Code
Date Received02/09/2006
Decision Date 04/26/2006
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No