FDA 510(k)

CARDIOVIT FT-1

K号: K170182 · 2017-07-19

决定日期2017-07-19

产品代码DPS

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

CARDIOVIT FT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K170182. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CARDIOVIT FT-1?

CARDIOVIT FT-1 is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Schiller AG. The 510(k) number is K170182.

When did CARDIOVIT FT-1 receive FDA 510(k) clearance?

CARDIOVIT FT-1 received FDA 510(k) clearance on 2017-07-19, under 510(k) number K170182.

Who is the listed applicant for CARDIOVIT FT-1?

FDA 510(k)记录显示Schiller AG为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for CARDIOVIT FT-1?

The FDA product code for CARDIOVIT FT-1 is DPS.

列明Schiller AG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。

K253562medilogFD K221056ARGUS PB-3000 K183425CARDIOVIT AT-102 G2 K152043诊断站 DS20

官方来源

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