FDA 510(k)

Calcium2

K号: K244042 · 2025-02-10

决定日期2025-02-10

产品代码CJY

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Calcium2 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Ireland. It received FDA 510(k) clearance on 2025-02-10 under 510(k) number K244042. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Calcium2?

Calcium2 is a medical device that received FDA 510(k) clearance on 2025-02-10. The listed applicant is Abbott Ireland. The 510(k) number is K244042.

When did Calcium2 receive FDA 510(k) clearance?

Calcium2 received FDA 510(k) clearance on 2025-02-10, under 510(k) number K244042.

Who is the listed applicant for Calcium2?

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

What is the FDA product code for Calcium2?

The FDA product code for Calcium2 is CJY.

列明Abbott Ireland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。

K252357Glucose2

官方来源

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