YO Home Sperm Test

Semen Analysis Device

MEDICAL ELECTRONIC SYSTEMS, LTD

The following data is part of a premarket notification filed by Medical Electronic Systems, Ltd with the FDA for Yo Home Sperm Test.

Pre-market Notification Details

Device IDK161493
510k NumberK161493
Device Name:YO Home Sperm Test
ClassificationSemen Analysis Device
Applicant MEDICAL ELECTRONIC SYSTEMS, LTD ALON HATAVOR ST.20 ZONE 6 Caesarea Ind. Park,  IL 38900
ContactMarcia Deutsch
CorrespondentErika Ammirati
AMMIRATI REGULATORY CONSULTING 575 SHIRLYNN COURT Los Altos,  CA  94022
Product CodePOV  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-01
Decision Date2016-11-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290016650273 K161493 000
07290016650365 K161493 000
07290016650358 K161493 000
07290016650341 K161493 000

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