Omeza 胶原基质
K号: K211972 · 2021-09-01
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器械摘要
Omeza Collagen Matrix is the device name listed in this FDA 510(k) record. The listed applicant is Omeza, LLC. It received FDA 510(k) clearance on 2021-09-01 under 510(k) number K211972. 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 Omeza Collagen Matrix?
Omeza Collagen Matrix is a medical device that received FDA 510(k) clearance on 2021-09-01. The listed applicant is Omeza, LLC. The 510(k) number is K211972.
When did Omeza Collagen Matrix receive FDA 510(k) clearance?
Omeza Collagen Matrix received FDA 510(k) clearance on 2021-09-01, under 510(k) number K211972.
Who is the listed applicant for Omeza Collagen Matrix?
The FDA 510(k) record lists Omeza, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Omeza Collagen Matrix?
The FDA product code for Omeza Collagen Matrix 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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