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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 system, documentation, breast lesion
De Novo Number DEN020001
510(K) Number K010514
Device Name BREASTVIEW VISUAL MAPPING SYSTEM
Requester
assurance medical
555 thirteenth st., nw
washington,  DC  20004 -1109
Contact howard m holstein
Regulation Number884.2990
Classification Product Code
NKA  
Date Received05/28/2002
Decision Date 01/31/2003
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
-
-