FDA 510(k)

Tyto Insights for Wheeze Detection

K号: K232237 · 2023-12-13

决定日期2023-12-13

产品代码PHZ

咨询委员会AN

决定Substantially Equivalent

器械摘要

Tyto Insights for Wheeze 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 2023-12-13 under 510(k) number K232237. 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 Wheeze Detection?

Tyto Insights for Wheeze Detection is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Tyto Care , Ltd.. The 510(k) number is K232237.

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

Tyto Insights for Wheeze Detection received FDA 510(k) clearance on 2023-12-13, under 510(k) number K232237.

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

The FDA product code for Tyto Insights for Wheeze 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。

K252844Tyto Insights for Wheeze Detection (with PCCP)K252089Tyto Stethoscope (G3)K243567Tyto Insights for Rhonchi Detection K240555Tyto Insights for Crackles Detection K221614TytoCare Lung Sounds Analyzer K190242Tyto Thermometer

查看所有 9 个设备 →

官方来源

在 FDA 数据库中查看 →

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。