FDA 510(k) Application Details - K241626

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K241626
Device Name	Labware, Assisted Reproduction
Applicant	iPreg Incorporation 4F-3., No. 77, Sec. 1, Xintai 5th Rd., Xizhi Dist. New Taipei City 221 TW Other 510(k) Applications for this Company
Contact	Ching-Wen Chang Other 510(k) Applications for this Contact
Regulation Number	884.6160   More FDA Info for this Regulation Number
Classification Product Code	MQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2024
Decision Date	02/20/2025
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