FDA 510(k) Application Details - K232980

Device Classification Name	Labware, Assisted Reproduction   More FDA Info for this Device
510(K) Number	K232980
Device Name	Labware, Assisted Reproduction
Applicant	CytoSwim Ltd Unit 34, The Venture Centre, University of Warwick Science Park, Coventry CV4 7EZ GB Other 510(k) Applications for this Company
Contact	Max Meissner 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	09/21/2023
Decision Date	03/14/2024
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