FDA 510(k) Application Details - K250897

Device Classification Name	Transducer, Pressure, Intrauterine   More FDA Info for this Device
510(K) Number	K250897
Device Name	Transducer, Pressure, Intrauterine
Applicant	Clinical Innovations LLC 747 W 4170 S Murray, UT 84047 US Other 510(k) Applications for this Company
Contact	Alex Garrett Other 510(k) Applications for this Contact
Regulation Number	884.2700   More FDA Info for this Regulation Number
Classification Product Code	HFN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2025
Decision Date	05/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review