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, imaging, gastrointestinal, wireless, capsule
De Novo Number DEN010002
510(K) Number K010312
Device Name GIVEN DIAGNOSTIC IMAGING SYSTEM
Requester
GIVEN IMAGING LTD.
117 ahuzah st.
ra'ananna,  IL 43373
Contact shoshana friedman
Regulation Number876.1300
Classification Product Code
NEZ  
Date Received06/11/2001
Decision Date 08/01/2001
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Type Post-NSE
-
-