EchoMD 自动射血分数软件
K号: K173780 · 2018-06-14
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器械摘要
EchoMD Automated Ejection Fraction Software is the device name listed in this FDA 510(k) record. The listed applicant is Bay Labs, Inc.. It received FDA 510(k) clearance on 2018-06-14 under 510(k) number K173780. 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 EchoMD Automated Ejection Fraction Software?
EchoMD Automated Ejection Fraction Software is a medical device that received FDA 510(k) clearance on 2018-06-14. The listed applicant is Bay Labs, Inc.. The 510(k) number is K173780.
When did EchoMD Automated Ejection Fraction Software receive FDA 510(k) clearance?
EchoMD Automated Ejection Fraction Software received FDA 510(k) clearance on 2018-06-14, under 510(k) number K173780.
Who is the listed applicant for EchoMD Automated Ejection Fraction Software?
The FDA 510(k) record lists Bay Labs, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EchoMD Automated Ejection Fraction Software?
The FDA product code for EchoMD Automated Ejection Fraction Software is LLZ.
相关临床试验
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相关器械（代码：LLZ）
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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