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 device, fertility diagnostic, contraceptive, software application
De Novo Number DEN170052
Device Name Natural Cycles
Requester
Natural Cycles Nordic AB
luntmakargatan 26
stockholm,  SE 111-37
Contact raoul scherwitzl
Regulation Number884.5370
Classification Product Code
PYT  
Date Received09/20/2017
Decision Date 08/10/2018
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
-
-