FDA 510(k)

SwimCount® 收割器（1 mL）；SwimCount® 收割器（3 mL）

K号: K241348 · 2025-01-31

决定日期2025-01-31

产品代码MQK

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决定实质等同

器械摘要

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.

常见问题

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.

列明Motilitycount Aps为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K183602SwimCount 精子质量测试

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。