CuffGuard
K号: K243562 · 2025-08-12
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申请人Idmed
决定日期2025-08-12
产品代码BSK
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。
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器械摘要
CuffGuard is the device name listed in this FDA 510(k) record. The listed applicant is Idmed. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K243562. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CuffGuard?
CuffGuard is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Idmed. The 510(k) number is K243562.
When did CuffGuard receive FDA 510(k) clearance?
CuffGuard received FDA 510(k) clearance on 2025-08-12, under 510(k) number K243562.
Who is the listed applicant for CuffGuard?
The FDA 510(k) record lists Idmed as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CuffGuard?
The FDA product code for CuffGuard is BSK.
相关临床试验
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列明Idmed为申报人的其他记录
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相关器械（代码：BSK）
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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