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FDA 510(k)

QUANTIEN 测量系统

K号: K172182 · 2017-08-18

决定日期2017-08-18
产品代码DQK
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

QUANTIEN Measurement System is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical (Now Part of the Abbott Medical). It received FDA 510(k) clearance on 2017-08-18 under 510(k) number K172182. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QUANTIEN Measurement System?

QUANTIEN Measurement System is a medical device that received FDA 510(k) clearance on 2017-08-18. The listed applicant is St. Jude Medical (Now Part of the Abbott Medical). The 510(k) number is K172182.

When did QUANTIEN Measurement System receive FDA 510(k) clearance?

QUANTIEN Measurement System received FDA 510(k) clearance on 2017-08-18, under 510(k) number K172182.

Who is the listed applicant for QUANTIEN Measurement System?

The FDA 510(k) record lists St. Jude Medical (Now Part of the Abbott Medical) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTIEN Measurement System?

The FDA product code for QUANTIEN Measurement System is DQK.

相关临床试验

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。

相关器械(代码:DQK)

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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