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 Back To Search Results
Device Classification Name Burn Resuscitation Decision Support Software
510(k) Number K140387
Device Name Burn Resuscitation Decision Support System - Clinical (BRDSS-C)
Applicant
The Surgeon General, Department of the Army
1430 Veterans Dr.
Fort Detrick,  MD  21702
Applicant Contact KENNETH A BERTRAM, MD, PHD
Correspondent
The Surgeon General, Department of the Army
1430 Veterans Dr.
Fort Detrick,  MD  21702
Correspondent Contact KENNETH A BERTRAM, MD, PHD
Regulation Number868.1890
Classification Product Code
PDT  
Date Received02/14/2014
Decision Date 12/23/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-