FDA 510(k)

茧状对流加温系统，型号CWS7000

K号: K232502 · 2024-02-21

决定日期2024-02-21

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

Cocoon Convective Warming System, Model CWS7000 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 2024-02-21 under 510(k) number K232502. 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, Model CWS7000?

Cocoon Convective Warming System, Model CWS7000 is a medical device that received FDA 510(k) clearance on 2024-02-21. The listed applicant is Care Essentials Pty, Ltd.. The 510(k) number is K232502.

When did Cocoon Convective Warming System, Model CWS7000 receive FDA 510(k) clearance?

Cocoon Convective Warming System, Model CWS7000 received FDA 510(k) clearance on 2024-02-21, under 510(k) number K232502.

Who is the listed applicant for Cocoon Convective Warming System, Model CWS7000?

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, Model CWS7000?

The FDA product code for Cocoon Convective Warming System, Model CWS7000 is DWJ.

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。

K213907CareGUARD 消毒包装 K181671茧状对流加温系统

官方来源

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