RTHawk, HeartVista 心脏包
K号: K153740 · 2016-06-30
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器械摘要
RTHawk, HeartVista Cardiac Package is the device name listed in this FDA 510(k) record. The listed applicant is Heartvista, Inc.. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K153740. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RTHawk, HeartVista Cardiac Package?
RTHawk, HeartVista Cardiac Package is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Heartvista, Inc.. The 510(k) number is K153740.
When did RTHawk, HeartVista Cardiac Package receive FDA 510(k) clearance?
RTHawk, HeartVista Cardiac Package received FDA 510(k) clearance on 2016-06-30, under 510(k) number K153740.
Who is the listed applicant for RTHawk, HeartVista Cardiac Package?
The FDA 510(k) record lists Heartvista, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RTHawk, HeartVista Cardiac Package?
The FDA product code for RTHawk, HeartVista Cardiac Package is LNH.
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Heartvista, Inc.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：LNH）
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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