SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)— 510(k) K241348
Substantially EquivalentMotilitycount Aps
FDA 510(k) clearance K241348 for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL), Substantially Equivalent on 2025-01-31. Applicant: Motilitycount Aps. Device class: 2.
Clearance details
- Applicant
- Motilitycount Aps
- Product code
- Code MQK
- Device class
- Class 2
- Regulation
- 21 CFR 884.6160
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Valby, DK
Recent devices under product code MQK
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