DEKA Loop
K号: K234055 · 2024-03-13
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决定日期2024-03-13
产品代码QJI
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
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器械摘要
DEKA Loop is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2024-03-13 under 510(k) number K234055. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DEKA Loop?
DEKA Loop is a medical device that received FDA 510(k) clearance on 2024-03-13. The listed applicant is Deka Research and Development. The 510(k) number is K234055.
When did DEKA Loop receive FDA 510(k) clearance?
DEKA Loop received FDA 510(k) clearance on 2024-03-13, under 510(k) number K234055.
Who is the listed applicant for DEKA Loop?
The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DEKA Loop?
The FDA product code for DEKA Loop is QJI.
列明Deka Research and Development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。
相关器械（代码：QJI）
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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