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, blood mixing and blood weighing
510(k) Number BK900026
Tradename SEBRA MODEL #1040, DIGITAL BLOOD SHAKER/WEIGHT MONITOR
Device Name Device, Blood Mixing and Weighing
Original Applicant
Engineering & Research Associates, Inc.
500 north tucson boulevard (era plaza)
tucson,  AZ  85716
Regulation Number864.9195
Classification Product Code
KSQ  
Date Received08/17/1990
Decision Date 06/26/1991
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
-
-