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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Semen Analysis 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,  IL 3088900
Applicant Contact Marcia Deutsch
Correspondent
Medical Electronic Systems , Ltd.
Alon Hatavor 20, Zone 6, Caesarea Industrial Park
Caesarea,  IL 3088900
Correspondent Contact Taly Vider Cohen
Regulation Number864.5220
Classification Product Code
POV  
Date Received03/22/2022
Decision Date 08/07/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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