Natural Cycles

Device, Fertility Diagnostic, Contraceptive, Software Application

Natural Cycles Nordic AB

The following data is part of a De Novo classification by Natural Cycles Nordic Ab with the FDA for Natural Cycles.

Pre-market Notification Details

DeNovo IDDEN170052
Device Name:Natural Cycles
ClassificationDevice, Fertility Diagnostic, Contraceptive, Software Application
Applicant Natural Cycles Nordic AB luntmakargatan 26 Stockholm,  SE 111-37
ContactRaoul Scherwitzl
Product CodePYT  
CFR Regulation Number884.5370 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardObstetrics/Gynecology
Classification AdvisoryObstetrics/Gynecology
TypePost-NSE
Date Received2017-09-20
Decision Date2018-08-10
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07350014630131 DEN170052 000
07350014630124 DEN170052 000

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