FDA 510(k)

Crossloop

K号: K241962 · 2025-03-27

决定日期2025-03-27

产品代码DQX

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Crossloop is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K241962. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Crossloop?

Crossloop is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K241962.

When did Crossloop receive FDA 510(k) clearance?

Crossloop received FDA 510(k) clearance on 2025-03-27, under 510(k) number K241962.

Who is the listed applicant for Crossloop?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Crossloop?

The FDA product code for Crossloop is DQX.

列明Asahi Intecc Co., Ltd.为申报人的其他记录

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