FDA 510(k) Application Details - K183602

Device Classification Name	More FDA Info for this Device
510(K) Number	K183602
Device Name	SwimCount Sperm Quality Test
Applicant	MotilityCount ApS G1. Koge Landevej 55 Valby DK-2500 DK Other 510(k) Applications for this Company
Contact	Jacob Mollenbach Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2018
Decision Date	06/27/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review