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 pediatric hemodialysis system
De Novo Number DEN180055
Device Name CARPEDIEM System
Requester
bellco srl (now part of medtronic, inc)
via camurana 1
mirandola,  IT 41037
Contact matteo chiappini
Regulation Number876.5861
Classification Product Code
QIR  
Date Received10/09/2018
Decision Date 04/29/2020
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-