Microlyte Ag
K号: K153756 · 2016-08-04
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器械摘要
Microlyte Ag is the device name listed in this FDA 510(k) record. The listed applicant is Imbed Biosciences, Inc.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K153756. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
常见问题
What is the Microlyte Ag?
Microlyte Ag is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Imbed Biosciences, Inc.. The 510(k) number is K153756.
When did Microlyte Ag receive FDA 510(k) clearance?
Microlyte Ag received FDA 510(k) clearance on 2016-08-04, under 510(k) number K153756.
Who is the listed applicant for Microlyte Ag?
The FDA 510(k) record lists Imbed Biosciences, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Microlyte Ag?
The FDA product code for Microlyte Ag is FRO. This falls under the Anesthesiology category.
相关临床试验
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相关器械（代码：FRO）
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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