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FDA 510(k)

Thora-3Di,型号 T-01

K号: K151940 · 2016-03-10

决定日期2016-03-10
产品代码BZQ
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

Thora-3Di, Model T-01 is the device name listed in this FDA 510(k) record. The listed applicant is Pneumacare Limited. It received FDA 510(k) clearance on 2016-03-10 under 510(k) number K151940. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Thora-3Di, Model T-01?

Thora-3Di, Model T-01 is a medical device that received FDA 510(k) clearance on 2016-03-10. The listed applicant is Pneumacare Limited. The 510(k) number is K151940.

When did Thora-3Di, Model T-01 receive FDA 510(k) clearance?

Thora-3Di, Model T-01 received FDA 510(k) clearance on 2016-03-10, under 510(k) number K151940.

Who is the listed applicant for Thora-3Di, Model T-01?

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

What is the FDA product code for Thora-3Di, Model T-01?

The FDA product code for Thora-3Di, Model T-01 is BZQ.

相关临床试验

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。

相关器械(代码:BZQ)

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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