K-number	K183602
Device name	SwimCount Sperm Quality Test
Applicant	Motilitycount Aps
Product code	POV
Device class	Class II
Decision date	Jun 27, 2019
Decision	Substantially Equivalent
Regulation	864.5220

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Source

View the full FDA submission: accessdata.fda.gov

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SwimCount Sperm Quality Test

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