CARESCAPE Central Station V2
K号: K162012 · 2016-09-15
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器械摘要
CARESCAPE Central Station V2 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K162012. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CARESCAPE Central Station V2?
CARESCAPE Central Station V2 is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is GE Healthcare. The 510(k) number is K162012.
When did CARESCAPE Central Station V2 receive FDA 510(k) clearance?
CARESCAPE Central Station V2 received FDA 510(k) clearance on 2016-09-15, under 510(k) number K162012.
Who is the listed applicant for CARESCAPE Central Station V2?
The FDA 510(k) record lists GE Healthcare as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CARESCAPE Central Station V2?
The FDA product code for CARESCAPE Central Station V2 is DXJ.
相关临床试验
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列明GE Healthcare为申报人的其他记录
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相关器械（代码：DXJ）
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
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