Atmo 气囊系统
K号: K253569 · 2026-05-22
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决定日期2026-05-22
产品代码NYV
咨询委员会GU
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决定实质等同
器械摘要
Atmo Gas Capsule System is the device name listed in this FDA 510(k) record. The listed applicant is Atmo Biosciences, Ltd.. It received FDA 510(k) clearance on 2026-05-22 under 510(k) number K253569. The device is classified under product code NYV. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Atmo Gas Capsule System?
Atmo Gas Capsule System is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Atmo Biosciences, Ltd.. The 510(k) number is K253569.
When did Atmo Gas Capsule System receive FDA 510(k) clearance?
Atmo Gas Capsule System received FDA 510(k) clearance on 2026-05-22, under 510(k) number K253569.
Who is the listed applicant for Atmo Gas Capsule System?
The FDA 510(k) record lists Atmo Biosciences, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Atmo Gas Capsule System?
The FDA product code for Atmo Gas Capsule System is NYV.
相关临床试验
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列明Atmo Biosciences, Ltd.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：NYV）
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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