FDA 510(k)

RFP-100A 连接电缆（一次性使用）

K号: K230571 · 2023-05-30

决定日期2023-05-30

产品代码DSA

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

RFP-100A Connector Cable (Single Use) is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Technologies, Inc.. It received FDA 510(k) clearance on 2023-05-30 under 510(k) number K230571. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RFP-100A Connector Cable (Single Use)?

RFP-100A Connector Cable (Single Use) is a medical device that received FDA 510(k) clearance on 2023-05-30. The listed applicant is Baylis Medical Technologies, Inc.. The 510(k) number is K230571.

When did RFP-100A Connector Cable (Single Use) receive FDA 510(k) clearance?

RFP-100A Connector Cable (Single Use) received FDA 510(k) clearance on 2023-05-30, under 510(k) number K230571.

Who is the listed applicant for RFP-100A Connector Cable (Single Use)?

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

What is the FDA product code for RFP-100A Connector Cable (Single Use)?

The FDA product code for RFP-100A Connector Cable (Single Use) is DSA.

列明Baylis Medical Technologies, 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。

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相关器械（代码：DSA）

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。

官方来源

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