YO Home Sperm Test
K-Number: K241628 · 2024-11-29
ApplicantMedical Electronic Systems , Ltd.
Decision Date2024-11-29
Product CodePOV
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
YO Home Sperm Test is a medical device manufactured by Medical Electronic Systems , Ltd.. It received FDA 510(k) clearance on 2024-11-29 under approval number K241628. The device is classified under product code POV. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the YO Home Sperm Test?
YO Home Sperm Test is a medical device that received FDA 510(k) clearance on 2024-11-29. It is manufactured by Medical Electronic Systems , Ltd.. The 510(k) number is K241628.
When was YO Home Sperm Test approved by the FDA?
YO Home Sperm Test received FDA 510(k) clearance on 2024-11-29, under approval number K241628.
What company makes YO Home Sperm Test?
YO Home Sperm Test is manufactured by Medical Electronic Systems , Ltd..
What is the FDA product code for YO Home Sperm Test?
The FDA product code for YO Home Sperm Test is POV.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.