BreathID® Smart System
K号: K223185 · 2022-11-10
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决定日期2022-11-10
产品代码MSQ
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器械摘要
BreathID® Smart System is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience Israel , Ltd.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K223185. The device is classified under product code MSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BreathID® Smart System?
BreathID® Smart System is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Meridian Bioscience Israel , Ltd.. The 510(k) number is K223185.
When did BreathID® Smart System receive FDA 510(k) clearance?
BreathID® Smart System received FDA 510(k) clearance on 2022-11-10, under 510(k) number K223185.
Who is the listed applicant for BreathID® Smart System?
The FDA 510(k) record lists Meridian Bioscience Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BreathID® Smart System?
The FDA product code for BreathID® Smart System is MSQ.
相关临床试验
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。
列明Meridian Bioscience Israel , 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：MSQ）
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。
K221896BreathID Hp SystemMeridian Bioscience Israel , Ltd.K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , Ltd.K193610BreathID Smart SystemExalenz Bioscience , Ltd.K173777BreathID Hp Lab SystemExalenz Bioscience , Ltd.K173772BreathID Hp SystemExalenz Bioscience , Ltd.K162150BreathID Hp Lab SystemExalenz Bioscience , Ltd.
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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