iNtuition-结构性心脏病模块
K号: K191585 · 2019-07-12
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器械摘要
iNtuition-Structural Heart Module is the device name listed in this FDA 510(k) record. The listed applicant is Terarecon,Inc.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K191585. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the iNtuition-Structural Heart Module?
iNtuition-Structural Heart Module is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Terarecon,Inc.. The 510(k) number is K191585.
When did iNtuition-Structural Heart Module receive FDA 510(k) clearance?
iNtuition-Structural Heart Module received FDA 510(k) clearance on 2019-07-12, under 510(k) number K191585.
Who is the listed applicant for iNtuition-Structural Heart Module?
The FDA 510(k) record lists Terarecon,Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iNtuition-Structural Heart Module?
The FDA product code for iNtuition-Structural Heart Module is LLZ.
相关临床试验
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列明Terarecon,Inc.为申报人的其他记录
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相关器械（代码：LLZ）
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官方来源
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