FDA 510(k) Application Details - K243114

Device Classification Name	More FDA Info for this Device
510(K) Number	K243114
Device Name	SQA-iOw Sperm Quality Analyzer
Applicant	Medical Electronic Systems Ltd. Alon Hatavor St. 20 Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Taly Vider Cohen 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	09/30/2024
Decision Date	05/02/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Dual Track
Reviewed By Third Party	N
Expedited Review