FDA 510(k)

RVS-100 生命体征监测仪

K号: K170538 · 2017-10-17

决定日期2017-10-17

产品代码MWI

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

RVS-100 Vital Signs Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Rudolf Riester GmbH. It received FDA 510(k) clearance on 2017-10-17 under 510(k) number K170538. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RVS-100 Vital Signs Monitor?

RVS-100 Vital Signs Monitor is a medical device that received FDA 510(k) clearance on 2017-10-17. The listed applicant is Rudolf Riester GmbH. The 510(k) number is K170538.

When did RVS-100 Vital Signs Monitor receive FDA 510(k) clearance?

RVS-100 Vital Signs Monitor received FDA 510(k) clearance on 2017-10-17, under 510(k) number K170538.

Who is the listed applicant for RVS-100 Vital Signs Monitor?

The FDA 510(k) record lists Rudolf Riester GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RVS-100 Vital Signs Monitor?

The FDA product code for RVS-100 Vital Signs Monitor is MWI.

列明Rudolf Riester GmbH为申报人的其他记录

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