Thermalite 加热 CPAP 管道（CTUBH06H15DS-2, CTUBH15-DS）
K号: K241268 · 2024-08-02
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决定日期2024-08-02
产品代码BZE
咨询委员会AN
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决定实质等同
器械摘要
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is the device name listed in this FDA 510(k) record. The listed applicant is Exceleron Medical. It received FDA 510(k) clearance on 2024-08-02 under 510(k) number K241268. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is a medical device that received FDA 510(k) clearance on 2024-08-02. The listed applicant is Exceleron Medical. The 510(k) number is K241268.
When did Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) receive FDA 510(k) clearance?
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) received FDA 510(k) clearance on 2024-08-02, under 510(k) number K241268.
Who is the listed applicant for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?
The FDA 510(k) record lists Exceleron Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)?
The FDA product code for Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) is BZE.
相关临床试验
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相关器械（代码：BZE）
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
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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