SwimCount Sperm Quality Test

Semen Analysis Device

MotilityCount ApS

The following data is part of a premarket notification filed by Motilitycount Aps with the FDA for Swimcount Sperm Quality Test.

Pre-market Notification Details

Device IDK183602
510k NumberK183602
Device Name:SwimCount Sperm Quality Test
ClassificationSemen Analysis Device
Applicant MotilityCount ApS G1. Koge Landevej 55 Valby,  DK Dk-2500
ContactJacob Mollenbach
CorrespondentJacob Mollenbach
MotilityCount ApS G1. Koge Landevej 55 Valby,  DK Dk-2500
Product CodePOV  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-06-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843277100048 K183602 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.