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510(k) K202897

Device
Natural Cycles
Applicant
Natural Cycles Nordic AB
510(k) number
K202897
Product code
PYT  
Decision
Substantially Equivalent (SESE)
Decision date
2021-06-24
Date received
2020-09-29
Regulation
884.5370
Classification name
Device, Fertility Diagnostic, Contraceptive, Software Application
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Raoul Scherwitzl
Address
St Eriksgatan 63b Stockholm SE 112 34 112 34

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250561Natural CyclesNatural Cycles Nordic AB2025-03-21
K241006Natural CyclesNatural Cycles Nordic AB2024-07-11
K231274Natural CyclesNatural Cycles Nordic AB2023-08-24
K193330Clue Birth ControlBiowink GmbH2021-02-18
DEN170052Natural CyclesNatural Cycles Nordic AB2018-08-10

Legacy Summary#

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FDA Review#

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