FDA 510(k)

Biowy Tym 管道 (TT)

K号: K233658 · 2024-02-16

决定日期2024-02-16

产品代码ETD

咨询委员会医疗设备监管文本描述翻译如下：关于[公司/产品名称]的监管信息： - 美国食品药品监督管理局（FDA）批准号：[510(k)编号] - 预市场批准（PMA）申请号：[PMA编号] - 临床试验注册号（NCT）：[NCT编号] - 医学文献标识符（PMID）：[PMID编号] - 产品标识符：[标识符] - 相关政策：医疗监管政策v1 - 更多信息请访问：[URL] 请注意，以上翻译保留了公司/产品名称、FDA、510(k)、PMA、NCT、PMID、标识符和URL。

决定实质等同

器械摘要

Biowy Tym Tube (TT) is the device name listed in this FDA 510(k) record. The listed applicant is Biowy Corporation. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K233658. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biowy Tym Tube (TT)?

Biowy Tym Tube (TT) is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Biowy Corporation. The 510(k) number is K233658.

When did Biowy Tym Tube (TT) receive FDA 510(k) clearance?

Biowy Tym Tube (TT) received FDA 510(k) clearance on 2024-02-16, under 510(k) number K233658.

Who is the listed applicant for Biowy Tym Tube (TT)?

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

What is the FDA product code for Biowy Tym Tube (TT)?

The FDA product code for Biowy Tym Tube (TT) is ETD.

列明Biowy Corporation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。

K192246Biowy PICC 导管 S 套件 K173956Biowy PlCC 导管

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。