YO Home Sperm Test— 510(k) K161493

Name: FDA 510(k) clearance K161493
Creator: U.S. Food and Drug Administration
Published: 2016-11-08

Substantially Equivalent

Medical Electronic Systems , Ltd.

FDA 510(k) clearance K161493 for YO Home Sperm Test, Substantially Equivalent on 2016-11-08. Applicant: Medical Electronic Systems , Ltd.. Device class: 2.

Clearance details

Applicant: Medical Electronic Systems , Ltd.
Product code: Code POV
Device class: Class 2
Regulation: 21 CFR 864.5220
Advisory panel: Hematology
Date received: 2016-06-01
Decision date: 2016-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea Ind. Park, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.