FDA.report

510(k) K241628

Device
YO Home Sperm Test
Applicant
Medical Electronic Systems , Ltd.
510(k) number
K241628
Product code
POV
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-29
Date received
2024-06-06
Regulation
864.5220
Classification name
Semen Analysis Device
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Taly Vider Cohen
Address
Alon Hatavor St. 20 Caesarea IL 3088900 3088900

FDA Registration Numbers

Source Documents

510(k) summary PDF

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