BreathID Smart System
K号: K193610 · 2020-02-06
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决定日期2020-02-06
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 Exalenz Bioscience , Ltd.. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K193610. 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 2020-02-06. The listed applicant is Exalenz Bioscience , Ltd.. The 510(k) number is K193610.
When did BreathID Smart System receive FDA 510(k) clearance?
BreathID Smart System received FDA 510(k) clearance on 2020-02-06, under 510(k) number K193610.
Who is the listed applicant for BreathID Smart System?
The FDA 510(k) record lists Exalenz Bioscience , 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Exalenz Bioscience , 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.K223185BreathID® Smart SystemMeridian Bioscience Israel , Ltd.K220494BreathID Hp Lab System, BreathID Smart SystemMeridian Bioscience Israel , 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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