FDA 510(k)

Surveyor S2

K号: K182297 · 2019-01-24

决定日期2019-01-24

产品代码DRG

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

Surveyor S2 is the device name listed in this FDA 510(k) record. The listed applicant is Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2019-01-24 under 510(k) number K182297. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Surveyor S2?

Surveyor S2 is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Mortara Instrument, Inc.. The 510(k) number is K182297.

When did Surveyor S2 receive FDA 510(k) clearance?

Surveyor S2 received FDA 510(k) clearance on 2019-01-24, under 510(k) number K182297.

Who is the listed applicant for Surveyor S2?

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

What is the FDA product code for Surveyor S2?

The FDA product code for Surveyor S2 is DRG.

列明Mortara Instrument, 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。

K173765Surveyor患者监护仪 K161517Mortara Surveyor Patient Monitor K161465CardioConfirm K160685Surveyor S4移动监护仪 K152626H3+ Holter 记录仪 K152944Xscribe压力运动测试系统，Q-Stress压力运动测试系统

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官方来源

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