FDA 510(k)

HotDog Warming Mattress + Return Electrode

K号: K232627 · 2024-04-18

申请人Augustine Temperature Management, LLC

决定日期2024-04-18

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

HotDog Warming Mattress + Return Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Temperature Management, LLC. It received FDA 510(k) clearance on 2024-04-18 under 510(k) number K232627. 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 HotDog Warming Mattress + Return Electrode?

HotDog Warming Mattress + Return Electrode is a medical device that received FDA 510(k) clearance on 2024-04-18. The listed applicant is Augustine Temperature Management, LLC. The 510(k) number is K232627.

When did HotDog Warming Mattress + Return Electrode receive FDA 510(k) clearance?

HotDog Warming Mattress + Return Electrode received FDA 510(k) clearance on 2024-04-18, under 510(k) number K232627.

Who is the listed applicant for HotDog Warming Mattress + Return Electrode?

The FDA 510(k) record lists Augustine Temperature Management, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HotDog Warming Mattress + Return Electrode?

The FDA product code for HotDog Warming Mattress + Return Electrode is DWJ.

列明Augustine Temperature Management, LLC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。

K230866HotDog Warming Mattress + Return Electrode K210727HotDog Warming Mattress + Return Electrode

官方来源

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