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 Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name device, warming. blood and plasma
510(k) Number BK060050
Tradename Medi-Temp III, Model FW600 Blood/Fluid Warmer
Device Name Device, Warming, Blood and Plasma
Original Applicant
Gaymar Industries, Inc.
1700 pennsylvania avenue, n.w.
washington,  DC  20006 4706
Regulation Number864.9205
Classification Product Code
KZL  
Date Received08/14/2006
Decision Date 11/07/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
-
-