FDA 510(k)

BONHAWA呼吸加湿器

K号: K223863 · 2023-10-13

决定日期2023-10-13

产品代码BTT

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决定实质等同

器械摘要

BONHAWA Respiratory Humidifier is the device name listed in this FDA 510(k) record. The listed applicant is Telesair, Inc.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K223863. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BONHAWA Respiratory Humidifier?

BONHAWA Respiratory Humidifier is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Telesair, Inc.. The 510(k) number is K223863.

When did BONHAWA Respiratory Humidifier receive FDA 510(k) clearance?

BONHAWA Respiratory Humidifier received FDA 510(k) clearance on 2023-10-13, under 510(k) number K223863.

Who is the listed applicant for BONHAWA Respiratory Humidifier?

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

What is the FDA product code for BONHAWA Respiratory Humidifier?

The FDA product code for BONHAWA Respiratory Humidifier is BTT.

列明Telesair, Inc.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。

K251133AVEA 可弃用呼出过滤器/水阱 (11790)

相关器械（代码：BTT）

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。

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官方来源

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