K241348
- 510(k) number
- K241348
- Device name
- SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
- Applicant
- Motilitycount Aps DK
- Product code
- MQK — Labware, Assisted Reproduction
- Decision date
- 2025-01-31
- Date received
- 2024-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241348.pdf
Official FDA record: K241348
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.