FDA 510(k)

诊断站 DS20

K号: K152043 · 2016-05-06

决定日期2016-05-06

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

Diagnostic Station DS20 is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K152043. 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 Diagnostic Station DS20?

Diagnostic Station DS20 is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Schiller AG. The 510(k) number is K152043.

When did Diagnostic Station DS20 receive FDA 510(k) clearance?

Diagnostic Station DS20 received FDA 510(k) clearance on 2016-05-06, under 510(k) number K152043.

Who is the listed applicant for Diagnostic Station DS20?

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 Diagnostic Station DS20?

The FDA product code for Diagnostic Station DS20 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 K170182CARDIOVIT FT-1

官方来源

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