茧状对流加温系统
K号: K181671 · 2019-05-02
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决定日期2019-05-02
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：
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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
Cocoon Convective Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Care Essentials Pty, Ltd.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K181671. 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 Cocoon Convective Warming System?
Cocoon Convective Warming System is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Care Essentials Pty, Ltd.. The 510(k) number is K181671.
When did Cocoon Convective Warming System receive FDA 510(k) clearance?
Cocoon Convective Warming System received FDA 510(k) clearance on 2019-05-02, under 510(k) number K181671.
Who is the listed applicant for Cocoon Convective Warming System?
The FDA 510(k) record lists Care Essentials Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cocoon Convective Warming System?
The FDA product code for Cocoon Convective Warming System is DWJ.
相关临床试验
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。
列明Care Essentials Pty, Ltd.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。
相关器械（代码：DWJ）
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。
K262089一次性保暖毯Hangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® 加温系统The Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx™ 患者安全系统Stihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861加热系统Hangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun 温度管理系统 (型号 5000)Medivance, Inc.
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。
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