FDA 510(k) Application Details - K250561

Device Classification Name	More FDA Info for this Device
510(K) Number	K250561
Device Name	Natural Cycles
Applicant	NaturalCycles Nordic AB Sankt Eriksgatan 63 B Stockholm 112 34 SE Other 510(k) Applications for this Company
Contact	Megan Callanan Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PYT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2025
Decision Date	03/21/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review