FDA 510(k)

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

N.º K: K241348 · 2025-01-31

Fecha de decisión2025-01-31

Código de productoMQK

Comité asesorOB

DecisiónSubstantially Equivalent

Resumen del dispositivo

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is the device name listed in this FDA 510(k) record. The listed applicant is Motilitycount Aps. It received FDA 510(k) clearance on 2025-01-31 under 510(k) number K241348. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is a medical device that received FDA 510(k) clearance on 2025-01-31. The listed applicant is Motilitycount Aps. The 510(k) number is K241348.

When did SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) receive FDA 510(k) clearance?

SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) received FDA 510(k) clearance on 2025-01-31, under 510(k) number K241348.

Who is the listed applicant for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?

The FDA 510(k) record lists Motilitycount Aps as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)?

The FDA product code for SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL) is MQK.

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Otros registros que enlistan a Motilitycount Aps como solicitante

K183602SwimCount Sperm Quality Test

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Fuente oficial

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