• 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 blood establishment computer software and accessories
510(k) Number BK060037
Tradename Cerner Bridge Medical Transfusion Administration and Specimen Collections
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Cerner Corporation
2800 rock creek parkway
kansas city,  MO  64117 2551
Regulation Number864.9165
Classification Product Code
MMH  
Date Received07/03/2006
Decision Date 05/24/2007
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
-
-