AG100s
K号: K221477 · 2022-12-29
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决定日期2022-12-29
产品代码BSK
咨询委员会AN
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器械摘要
AG100s is the device name listed in this FDA 510(k) record. The listed applicant is Hospitech Respiration , Ltd.. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K221477. 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 AG100s?
AG100s is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Hospitech Respiration , Ltd.. The 510(k) number is K221477.
When did AG100s receive FDA 510(k) clearance?
AG100s received FDA 510(k) clearance on 2022-12-29, under 510(k) number K221477.
Who is the listed applicant for AG100s?
The FDA 510(k) record lists Hospitech Respiration , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AG100s?
The FDA product code for AG100s is BSK.
列明Hospitech Respiration , 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：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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