FDA 510(k)

TruWave 一次性压力传感器

K号: K183413 · 2019-05-01

决定日期2019-05-01

产品代码DXO

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

TruWave Disposable Pressure Transducer is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2019-05-01 under 510(k) number K183413. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TruWave Disposable Pressure Transducer?

TruWave Disposable Pressure Transducer is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is Edwards Lifeciences, LLC. The 510(k) number is K183413.

When did TruWave Disposable Pressure Transducer receive FDA 510(k) clearance?

TruWave Disposable Pressure Transducer received FDA 510(k) clearance on 2019-05-01, under 510(k) number K183413.

Who is the listed applicant for TruWave Disposable Pressure Transducer?

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

What is the FDA product code for TruWave Disposable Pressure Transducer?

The FDA product code for TruWave Disposable Pressure Transducer is DXO.

列明Edwards Lifeciences, 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。

K223127HemoSphere高级监测平台，HemoSphere ForeSight血氧饱和度电缆 K183646Acumen 低血压预测指数 – EV1000 临床平台，Acumen 低血压预测指数 – HemoSphere 高级监测平台，Acumen 低血压预测指数 – HemoSphere 高级监测平台 - 压力

官方来源

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