Thora-3Di,型号 T-01
K号: K151940 · 2016-03-10
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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
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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。
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。
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