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 computerized behavioral therapy device for treating symptoms
De Novo Number DEN200029
Device Name Parallel
Requester
Mahana Therapeutics, Inc.
230 california street, suite 302
san francisco,  CA  94111
Contact jean-noel courvoisier
Regulation Number876.5960
Classification Product Code
QMY  
Date Received04/30/2020
Decision Date 11/25/2020
Decision granted (DENG)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
Type Direct
-
-