BreathID Hp System
K号: K173772 · 2018-03-08
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决定日期2018-03-08
产品代码MSQ
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器械摘要
BreathID Hp 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 2018-03-08 under 510(k) number K173772. 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 Hp System?
BreathID Hp System is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Exalenz Bioscience , Ltd.. The 510(k) number is K173772.
When did BreathID Hp System receive FDA 510(k) clearance?
BreathID Hp System received FDA 510(k) clearance on 2018-03-08, under 510(k) number K173772.
Who is the listed applicant for BreathID Hp 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 Hp System?
The FDA product code for BreathID Hp 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.K193610BreathID Smart SystemExalenz Bioscience , Ltd.K173777BreathID Hp Lab 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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