FDA 510(k) Application Details - K220828

Device Classification Name	More FDA Info for this Device
510(K) Number	K220828
Device Name	SQA-iO Sperm Quality Analyzer
Applicant	Medical Electronic Systems LTD Alon Hatavor 20, Zone 6, Caesarea Industrial Park Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Marcia Deutsch 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	03/22/2022
Decision Date	08/07/2023
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