SilverStream 凝胶
K号: K200767 · 2020-10-08
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器械摘要
SilverStream Gel is the device name listed in this FDA 510(k) record. The listed applicant is Enzysurge , Ltd.. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K200767. 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 SilverStream Gel?
SilverStream Gel is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Enzysurge , Ltd.. The 510(k) number is K200767.
When did SilverStream Gel receive FDA 510(k) clearance?
SilverStream Gel received FDA 510(k) clearance on 2020-10-08, under 510(k) number K200767.
Who is the listed applicant for SilverStream Gel?
The FDA 510(k) record lists Enzysurge , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SilverStream Gel?
The FDA product code for SilverStream Gel 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
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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