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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 K241628
Device Name YO Home Sperm Test
Applicant
Medical Electronic Systems , Ltd.
Alon Hatavor St. 20
Caesarea,  IL 3088900
Applicant Contact Taly Vider Cohen
Correspondent
Medical Electronic Systems , Ltd.
Alon Hatavor St. 20
Caesarea,  IL 3088900
Correspondent Contact Taly Vider Cohen
Regulation Number864.5220
Classification Product Code
POV  
Date Received06/06/2024
Decision Date 11/29/2024
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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