潮池环
K号: K203689 · 2023-01-23
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决定日期2023-01-23
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
Tidepool Loop is the device name listed in this FDA 510(k) record. The listed applicant is Tidepool Project. It received FDA 510(k) clearance on 2023-01-23 under 510(k) number K203689. 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 Tidepool Loop?
Tidepool Loop is a medical device that received FDA 510(k) clearance on 2023-01-23. The listed applicant is Tidepool Project. The 510(k) number is K203689.
When did Tidepool Loop receive FDA 510(k) clearance?
Tidepool Loop received FDA 510(k) clearance on 2023-01-23, under 510(k) number K203689.
Who is the listed applicant for Tidepool Loop?
The FDA 510(k) record lists Tidepool Project as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tidepool Loop?
The FDA product code for Tidepool Loop is QJI.
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相关 PubMed 文献
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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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