FDA 510(k)

Arctic Sun 温度管理系统 (型号 5000)

K号: K251974 · 2025-10-24

决定日期2025-10-24

产品代码DWJ

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

Arctic Sun Temperature Management System (Model 5000) is the device name listed in this FDA 510(k) record. The listed applicant is Medivance, Inc.. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K251974. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Arctic Sun Temperature Management System (Model 5000)?

Arctic Sun Temperature Management System (Model 5000) is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Medivance, Inc.. The 510(k) number is K251974.

When did Arctic Sun Temperature Management System (Model 5000) receive FDA 510(k) clearance?

Arctic Sun Temperature Management System (Model 5000) received FDA 510(k) clearance on 2025-10-24, under 510(k) number K251974.

Who is the listed applicant for Arctic Sun Temperature Management System (Model 5000)?

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

What is the FDA product code for Arctic Sun Temperature Management System (Model 5000)?

The FDA product code for Arctic Sun Temperature Management System (Model 5000) is DWJ.

列明Medivance, Inc.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。

K243942Arctic Sun 统计温度管理系统 K200225Arctic Sun 统计温度管理系统 K161602Arctic Sun 温度管理系统

官方来源

在 FDA 数据库中查看 →

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。