FDA 510(k)

泰托洞察 - 哮鸣声检测

K号: K240555 · 2024-07-02

决定日期2024-07-02

产品代码PHZ

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Tyto Insights for Crackles Detection 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 2024-07-02 under 510(k) number K240555. The device is classified under product code PHZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tyto Insights for Crackles Detection?

Tyto Insights for Crackles Detection is a medical device that received FDA 510(k) clearance on 2024-07-02. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K240555.

When did Tyto Insights for Crackles Detection receive FDA 510(k) clearance?

Tyto Insights for Crackles Detection received FDA 510(k) clearance on 2024-07-02, under 510(k) number K240555.

Who is the listed applicant for Tyto Insights for Crackles Detection?

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 Insights for Crackles Detection?

The FDA product code for Tyto Insights for Crackles Detection is PHZ.

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 K232237泰托洞察器 - 喘鸣检测 K221614泰途医疗肺音分析仪 K190242泰托体温计

查看所有 9 个设备 →

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。