Deep Capsule® (Deep Capsule US)
K号: K250655 · 2026-03-12
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决定日期2026-03-12
产品代码QZF
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Deep Capsule® (Deep Capsule US) is the device name listed in this FDA 510(k) record. The listed applicant is Digestaid - Artificial Intelligence Development SA. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K250655. The device is classified under product code QZF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Deep Capsule® (Deep Capsule US)?
Deep Capsule® (Deep Capsule US) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Digestaid - Artificial Intelligence Development SA. The 510(k) number is K250655.
When did Deep Capsule® (Deep Capsule US) receive FDA 510(k) clearance?
Deep Capsule® (Deep Capsule US) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K250655.
Who is the listed applicant for Deep Capsule® (Deep Capsule US)?
The FDA 510(k) record lists Digestaid - Artificial Intelligence Development SA as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Deep Capsule® (Deep Capsule US)?
The FDA product code for Deep Capsule® (Deep Capsule US) is QZF.
相关临床试验
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相关器械（代码：QZF）
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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