FDA 510(k)

低血压决策辅助模型HDA-OR2

K号: K212529 · 2021-11-23

决定日期2021-11-23

产品代码DXG

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

Hypotension Decision Assist Model HDA-OR2 is the device name listed in this FDA 510(k) record. The listed applicant is Directed Systems, Ltd.. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K212529. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Hypotension Decision Assist Model HDA-OR2?

Hypotension Decision Assist Model HDA-OR2 is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Directed Systems, Ltd.. The 510(k) number is K212529.

When did Hypotension Decision Assist Model HDA-OR2 receive FDA 510(k) clearance?

Hypotension Decision Assist Model HDA-OR2 received FDA 510(k) clearance on 2021-11-23, under 510(k) number K212529.

Who is the listed applicant for Hypotension Decision Assist Model HDA-OR2?

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

What is the FDA product code for Hypotension Decision Assist Model HDA-OR2?

The FDA product code for Hypotension Decision Assist Model HDA-OR2 is DXG.

列明Directed Systems, 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。

K190955低血压决策辅助

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。