FDA 510(k)

泰托听诊器

K号: K160401 · 2016-10-19

决定日期2016-10-19

产品代码DQD

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

Tyto Stethoscope is the device name listed in this FDA 510(k) record. The listed applicant is Tyto Care , Ltd.. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K160401. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tyto Stethoscope?

Tyto Stethoscope is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K160401.

When did Tyto Stethoscope receive FDA 510(k) clearance?

Tyto Stethoscope received FDA 510(k) clearance on 2016-10-19, under 510(k) number K160401.

Who is the listed applicant for Tyto Stethoscope?

The FDA 510(k) record lists Tyto Care , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyto Stethoscope?

The FDA product code for Tyto Stethoscope is DQD.

列明Tyto Care , Ltd.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。

K252844泰托洞察器用于喘鸣检测（含PCCP）K252089泰托听诊器（G3）K243567Tyto Insights 哮鸣检测洞察 K240555泰托洞察 - 哮鸣声检测 K232237泰托洞察器 - 喘鸣检测 K221614泰途医疗肺音分析仪

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。