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510(k) K250561

Natural Cycles by Natural Cycles Nordic AB — Product Code PYT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 21, 2025
Date Received: February 25, 2025
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Device, Fertility Diagnostic, Contraceptive, Software Application
Device Class: Class II
Regulation Number: 884.5370
Review Panel: OB
Submission Type

Designed to monitor and provide fertility information to prevent pregnancy (contraception).