PROBEAT-V 及附件
K号: K153614 · 2016-04-21
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器械摘要
PROBEAT-V and accessories is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd., Health Care Company. It received FDA 510(k) clearance on 2016-04-21 under 510(k) number K153614. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PROBEAT-V and accessories?
PROBEAT-V and accessories is a medical device that received FDA 510(k) clearance on 2016-04-21. The listed applicant is Hitachi, Ltd., Health Care Company. The 510(k) number is K153614.
When did PROBEAT-V and accessories receive FDA 510(k) clearance?
PROBEAT-V and accessories received FDA 510(k) clearance on 2016-04-21, under 510(k) number K153614.
Who is the listed applicant for PROBEAT-V and accessories?
The FDA 510(k) record lists Hitachi, Ltd., Health Care Company as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PROBEAT-V and accessories?
The FDA product code for PROBEAT-V and accessories is LHN.
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。
相关器械（代码：LHN）
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。
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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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